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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94797

23 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 11, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

23 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Z-2557-2024
Recall number
Z-2557-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
2388 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number / UDI-DI / Lot Numbers: BRC-BAL-INT-SL/B 00884450363102 T2581281 BRC-BAL-INT-SL/B 00884450363102 T2594451 BRC-BAL-INT-SL/B 00884450363102 T2606225 BRC-BAL-INT-SL/B 00884450363102 T2609782 BRC-BAL-INT-SL/B 00884450363102 T2628321 BRC-BAL-INT-SL/B 00884450363102 T2643945 BRC-BAL-INT-SL/B 00884450363102 T2685079 BRC-BAL-INT-SL/B 00884450363102 T2712303 BRC-BAL-INT-SL/B 00884450363102 T2745782 BRC-BAL-INT-SL/B 00884450363102 T2758208 BRC-BAL-INT-SL/B 00884450363102 T2800973 BRC-BAL-INT-SL/B 00884450363102 T2805964 BRC-BAL-INT-SL/B 00884450363102 T2846532 BRC-BAL-INT-SL/B 00884450363102 T2846539 BRC-BAL-INT-SL/B 00884450363102 T2850757 BRC-BAL-INT-SL/B 00884450363102 T2901641

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 2 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac diagnostic and interventional procedures.

Z-2558-2024
Recall number
Z-2558-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
11837 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: K12T-10773 00884450426388 T2800379 T2824129 T2849013 T2857243 K12T-09284D 00884450602102 T2209872 T2220946 T2359067 T2364198 T2508160 T2674429 T2794927 T2800155 K12T-10621 00884450409435 T2308653 T2344516 T2411888 T2428905 T2429939 T2448507 T2452908 T2473123 T2498967 T2531706 T2597113 T2611405 T2629759 T2653268 T2685014 T2691082 T2715028 T2744136 T2776727 T2846077 T2873111 K12T-10800 00884450421093 T2280633 T2407018 T2503204 T2643484 T2680463 T2705035 T2885158 K12T-12491 00884450820605 T2905902

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 3 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CET300, The Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Catheter Extractor is indicated for use with tunneled, double lumen hemodialysis catheters with cuff sizes ranging from 10.8 French to 14.5 French.

Z-2559-2024
Recall number
Z-2559-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
3631 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number: CET200 UDI-DI code: 00884450052587 Lot Numbers: T2651502 T2700122 T2712304 T2748973 T2758209 T2779867 T2833064 T2850758 T2903817 Catalog Number: CET300 UDI-DI code: 00884450045497 T2626011 T2662043 T2701699 T2726893 T2750399 T2758210 T2805965 T2832137 T2849258 T2886083 T2921078

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 4 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit), REF: K02-00873A, Inject fluids into, or withdraw fluids from, the body.

Z-2560-2024
Recall number
Z-2560-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
3,647 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number: K02-00873A UDI-DI code: 00884450156261 Lot Numbers: H2597212 H2620955 H2641148 Catalog Number: K02-01105A UDI-DI code: 00884450156124 H2486384 H2542259 H2628908 Catalog Number: K02-01481A UDI-DI code: 00884450164464 H2387157 H2418377 H2472043 H2486729 H2507912 H2517550 H2526240 H2552843 H2595093 H2628968 H2655130 H2678790 H2699921 H2712471 H2747868 H2822453 H2831126 H2846806 H2868403 H2884580 H2897149 H2916452

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 5 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K04-00791A An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Z-2561-2024
Recall number
Z-2561-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
1,390 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number: K04-00791A UDI-DI code: 00884450148471 Lot Numbers: H2387533 H2408714 H2423858 H2447173 H2484854 H2509065 H2547204 H2557351 H2640509 H2669424 H2704230 H2770492 H2780739 H2792326 H2864128 H2869756 H2916432

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 6 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K K05-01890D K05-01945A K05-01954A K05-02247A K05-02436B K05-02507 K05-02511A K05-02954 K05-02982A To support various vascular or cardiac diagnostic and interventional procedures.

Z-2562-2024
Recall number
Z-2562-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
13,560 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484 Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot Numbers: H2397984 H2412868 H2426797 H2446029 H2450196 H2482980 H2492350 H2511643 H2539331 H2549658 H2583385 H2594873 H2629250 H2654820 H2673730 H2697598 H2739498 H2756187 H2770202 H2801817 H2819960 H2834477 H2845285 H2890830 H2912779 H2925275 Catalog Number: K05-00547J UDI-DI code: 00884450312049 Lot Numbers: H2645495 Catalog Number: K05-00612Q UDI-DI code: 00884450138519 Lot Numbers: H2629467 Catalog Number: K05-00819A UDI-DI code: 00884450273470 Lot Numbers: H2639243 Catalog Number: K05-01030H UDI-DI code: 00884450394502 Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246 Catalog Number: K05-01274D UDI-DI code: 00884450160596 Lot Numbers: H2628681 H2659930 Catalog Number: K05-01646 UDI-DI code: 00884450139240 Lot Numbers: H2468170 H2610232 H2669236 H2761568 H2834483 Catalog Number: K05-01688A UDI-DI code: 00884450450260 Lot Numbers: H2383009 H2397922 H2412414 H2430164 H2451023 H2454910 H2542861 H2576902 H2619765 H2718026 H2821398 H2823953 H2844957 H2846857 H2895319 Catalog Number: K05-01717B UDI-DI code: 00884450139325 Lot Numbers: H2404146S1 H2410692 H2476492 H2495715 H2516725 H2520817 H2548562 H2557492 H2564607 H2576953 H2589882 H2613573 H2640670 H2650871 H2697189 H2736533 H2767978 H2787955 H2823896 H2844892 H2849102 H2854783 H2864807 H2869821 H2911094 H2920493 Catalog Number: K05-01880K UDI-DI code: 00884450250082 Lot Numbers: H2415380 H2415389 H2520099 H2521297 H2558149 H2581890 H2602338 H2626908 H2725829 H2758376 H2787928 H2796059 H2810014 H2828097 H2859867 H2864769 H2874962 H2885296 H2899952 H2915446 H2927509 Catalog Number: K05-01890D UDI-DI code: 00884450448465 Lot Numbers: H2420188 H2470760 H2557921 H2581894 H2602345 H2641626 H2871425 Catalog Number: K05-01945A UDI-DI code: 00884450190425 Lot Numbers: H2629623 Catalog Number: K05-01954A UDI-DI code: 00884450200643 Lot Numbers: H2629622 Catalog Number: K05-02247A UDI-DI code: 00884450141915 Lot Numbers: H2632850 Catalog Number: K05-02436B UDI-DI code: 00884450450253 Lot Numbers: H2393542 H2429834 H2450827 H2490409 H2495792 H2526835 H2542711 H2564295 H2581946 H2643007 H2674545 H2681527 H2687258 H2899223 Catalog Number: K05-02507 UDI-DI code: 00884450136850 Lot Numbers: H2348365 H2353310 H2369280 H2385672 H2390242 H2398231 H2412975 H2416155 H2427243 H2436679 H2443286 H2446096 H2450076 H2466702 H2511700 H2516470 H2522736 H2533989 H2553744 H2560064 H2564513 H2584038 H2618874 H2629469 H2639227 H2645485 H2659923 H2675984 H2693156 H2721337 H2733185 H2746808 H2751331 H2779140 H2819920 H2871550 H2880714 H2925260 Catalog Number: K05-02511A UDI-DI code: 00884450543115 Lot Numbers: H2739521 H2765683 H2901045 Catalog Number: K05-02954 UDI-DI code: 00884450298350 Lot Numbers: H2725969 Catalog Number: K05-02982A UDI-DI code: 00884450639511 Lot Numbers: H2382003 H2420219

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 7 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

Z-2563-2024
Recall number
Z-2563-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
3,694 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H2897347 Catalog Number: K08-02948 UDI-DI code: 00884450250846 Lot Numbers: H2409549 H2421264 H2454187 H2471302 H2555399 H2560081 H2590001 H2608380 H2616367 H2641745 H2689450 H2718414 H2778302 H2824898 H2835712 H2849743 H2866799 H2875231 H2880035 Catalog Number: K08-03026 UDI-DI code: 00884450280416 Lot Numbers: H2414033 H2437895 H2474035 H2489683 H2518365 H2583262 H2584710 H2596210 H2836476 H2864917 H2881380 H2906069 H2912967 Catalog Number: K08-03119 UDI-DI code: 00884450333716 Lot Numbers: H2424087 H2465222 H2500943 H2519412 H2519413 H2708309 H2744000 H2806045 H2837641 H2846068 H2865870 H2872906 H2879960 H2912192

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 8 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.

Z-2564-2024
Recall number
Z-2564-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
188837 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number: K09-00526L UDI-DI code: 00884450410110 Lot Numbers: H2349153 H2383516 H2406764 H2413970 H2423156 H2448659 H2520716 H2575100 H2615198 H2703317 H2744465 H2756069 H2786999 H2795483 H2832682 H2866202 H2875102 H2925662 Catalog Number: K09-00807AH UDI-DI code: 00884450742365 Lot Numbers: H2746426 H2796444 H2796457 H2811125 H2824906 H2834319 H2846603 H2849847 H2875232 H2898333 H2898334 Catalog Number: K09-01467AD UDI-DI code: 00884450282441 Lot Numbers: H2361544 H2382954 H2412363 H2430072 H2450925 H2498356 H2518811 H2520081 H2542786 H2586501 H2641143 H2687299 H2758479 Catalog Number: K09-01467AF UDI-DI code: 00884450750575 Lot Numbers: H2663133 H2729165 H2782382 Catalog Number: K09-01514U UDI-DI code:00884450392539 Lot Numbers: H2369960 H2387656 H2425596 H2471303 H2506109 H2529512 H2564547 H2590002 H2616732 H2627662 H2666883 H2746432 H2770561 H2824896 H2841949 H2866790 H2897446 H2920615 Catalog Number: K09-01734L UDI-DI code:00884450585009 Lot Numbers: H2360817 H2387232 H2405472 H2442198 H2471391 H2488275 H2502884 H2528940 H2569420 H2587832 H2666928 H2676308 H2714908 H2740483 H2757855 H2780813 H2795414 H2809458 H2825037 H2837565 H2853628 H2890112 H2915671 Catalog Number: K09-02040C UDI-DI code: 00884450298312 Lot Numbers: H2512599 H2714847 Catalog Number: K09-02683F UDI-DI code: 00884450204597 Lot Numbers: H2487396 H2529031 H2559767 H2581856 H2595394 H2606455 H2676287 H2786364 H2841958 H2855547 Catalog Number: K09-02804B UDI-DI code: 00884450283738 Lot Numbers: H2746430 H2785501 H2804202 H2842009 H2890141 Catalog Number: K09-03844F UDI-DI code: 00884450205280 Lot Numbers: H2596165 Catalog Number: K09-04088H UDI-DI code: 00884450566374 Lot Numbers: H2426195 H2471388 H2473959 H2558086 H2581900 H2595432 H2615361 Catalog Number: K09-04088J UDI-DI code: 00884450743713 Lot Numbers: H2641900 H2691924 H2714049 H2722319 H2746454 H2825041 H2837221 H2899238 H2910128 Catalog Number: K09-04863J UDI-DI code: 00884450278642 Lot Numbers: H2405452 H2425982 H2431335 H2460807 H2480614 H2532106 H2569112 H2581867 H2606685 H2623838 H2648569 H2674453 H2715024 H2740801 H2749693 H2780765 H2818318 H2818319 H2847030 H2864031 H2910548 H2920663 Catalog Number: K09-04946B UDI-DI code: 00884450464540 Lot Numbers: H2642042 Catalog Number: K09-04998H UDI-DI code:00884450680131 Lot Numbers: H2430236 Catalog Number: K09-04998HP UDI-DI code: 00884450407349 Lot Numbers: H2409016 H2428494 H2469111 H2524740 H2546174 H2565082S1 H2734104 H2740664 H2766411 H2775481 H2803916 H2823823 H2841931 H2874354 H2896100 H2928526 Catalog Number: K09-05229JP UDI-DI code: 00884450206676 Lot Numbers: H2749821 H2764405 H2795137 H2824990 H2841954 H2863971 H2905112 Catalog Number: K09-05342A UDI-DI code: 00884450208649 Lot Numbers: H2413457 H2444223 H2474152 H2490841 H2508756 H2519305 H2545376 H2562513 H2585433 H2600537 H2642350 H2705154 H2709024 H2729368 H2749175 H2762973 H2776733 H2792236 H2800652 H2814845 H2833461 H2845963 H2866227 H2915961 H2927496 Catalog Number: K09-05375F UDI-DI code: 00884450223468 Lot Numbers: H2488306 H2835770 Catalog Number: K09-05939D UDI-DI code: 00884450224823 Lot Numbers: H2354795 H2381159 H2413459 H2434412 H2474054 H2475915 H2508758 H2550446 H2575409 H2600538 H2607144 H2630940 H2705169 H2744447 H2758271 H2762976 H2792240 H2819761 Catalog Number: K09-07759J UDI-DI code: 00884450628515 Lot Numbers: H2379532 H2387653 H2434868 H2471448 H2478110 H2520513 H2521340 H2539588 H2599403 H2640836 H2642292 H2687906 H2824846 H2833805 H2867113 H2920598 Catalog Number: K09-07789L UDI-DI code: 00884450573709 Lot Numbers: H2397265 H2413521 Catalog Number: K09-07789M UDI-DI code: 00884450680506 Lot Numbers: H2437839 H2448861 H2497890 H2520583 H2558117 H2565065S1 H2566492 H2596153 H2642183 H2685412 H2708246 H2758678 H2792401 H2814997 H2833726 H2846103 H2866069 H2885248 H2899257 Catalog Number: K09-07828U UDI-DI code: 00884450207369 Lot Numbers: H2398381 H2476400 H2496135 H2520086 H2687302 H2725977 Catalog Number: K09-07828UP UDI-DI code: 00884450299005 Lot Numbers: H2398380 H2412364 H2418719 H2430073 H2450929 H2476399 H2496134 H2527501 H2549705 H2557541 H2581987 H2586498 H2602705 H2626751 H2656809 H2671733 H2684453 H2693359 H2715287 H2763495 H2782384 H2804870 H2819132 H2821845 H2843973 H2854815 H2859913 H2879430 H2885390 H2901814 Catalog Number: K09-07834C UDI-DI code: 00884450209035 Lot Numbers: H2393352 H2408686 H2453224 H2488198 H2520848 H2539283 H2576576 H2601760 H2621100 H2666916 H2676281 H2740690 H2749606 H2780746 H2824989 H2841953 H2859346 H2890059 Catalog Number: K09-07905G UDI-DI code: 00884450398883 Lot Numbers: H2393373 H2434148 H2474571 H2488230 H2513034 H2532111 H2547551 H2587768 H2606690 H2641718 H2659700 H2681375 H2740390 H2795360 H2880252 Catalog Number: K09-08031D UDI-DI code: 00884450209073 Lot Numbers: H2413504 H2430271 H2469783 H2494696 H2519417 H2545402 H2585471 H2591222 H2600569 H2645326 H2685428 H2751545 H2792379 H2846071 H2850715 H2885221 H2912189 H2929578 Catalog Number: K09-08052Q UDI-DI code: 00884450334256 Lot Numbers: H2356024 H2369603 H2381990 H2409897 H2418734 H2442168 H2462882 H2520919 H2537621 H2547601 H2559166 H2559935 H2595422 H2652467 H2666873 H2726944 H2749120 H2749122 H2749123 H2780809 H2789329 H2813695 H2841994 H2853616 H2875339 H2890114 H2910131 Catalog Number: K09-08065J UDI-DI code: 00884450307700 Lot Numbers: H2347421 H2367047 H2388006 Catalog Number: K09-08150R UDI-DI code: 00884450625149 Lot Numbers: H2471450 H2476097 H2498497 H2529511 H2559983 H2641723 H2746422 H2770424 H2789391 H2804219 H2816942 H2859499 H2890144 H2915710 H2926591 Catalog Number: K09-08423G UDI-DI code: 00884450213919 Lot Numbers: H2451524 H2496241 H2576946 H2593400 H2697200 H2725761 H2849101 H2915458 Catalog Number: K09-08493KP UDI-DI code: 00884450276860 Lot Numbers: H2412255 H2439633 H2532894 H2562889 H2569232 H2592406 H2602617 H2619264 Catalog Number: K09-08847A UDI-DI code: 00884450254172 Lot Numbers: H2676867 H2718404 Catalog Number: K09-08875B UDI-DI code: 00884450564707 Lot Numbers: H2447079 H2525122 H2641701 H2667085 H2804116 Catalog Number: K09-09051H UDI-DI code: 00884450169773 Lot Numbers: H2471421 H2474377 H2480752 H2532711 H2666871 H2746487 H2757875 H2780831 H2804196 H2813738 H2847068 H2873191 H2880223 H2906182 H2915712 Catalog Number: K09-09184B UDI-DI code: 00884450209479 Lot Numbers: H2390285 H2398101 H2412190 H2429010 H2440019 H2451529 H2451673 H2460433 H2476484 H2496331 H2501782 H2509256 H2520762 H2544202 H2557463 H2565441 H2576947 H2593402 H2602349 H2619386 H2626854 H2641352 H2676857 H2869819 H2874999 H2889669 H2911084 H2920490 Catalog Number: K09-09403HP UDI-DI code: 00884450486740 Lot Numbers: H2749717 H2757815 H2770326 H2786374 H2795367 H2831595 H2880050 H2890063 Catalog Number: K09-09481A UDI-DI code: 00884450214770 Lot Numbers: H2354844 H2370975 H2397267 H2424096 H2430262 H2508975 H2540346 H2566494 H2591241 H2600583 H2630971 H2654806 H2658630 H2680861 H2729937 H2767954 H2792408 H2806164 H2819986 H2828953 H2850737 H2866132 H2871345 H2879991 H2929681 Catalog Number: K09-09499B UDI-DI code: 00884450214794 Lot Numbers: H2381976 H2405321 H2418641 H2446733 H2474568 H2512330 H2520853 H2547479 H2595389 H2614402 H2629219 H2666866 H2676285 H2713985 H2740377 H2764411 H2780751 H2803993 H2831580 H2847023 H2890064 Catalog Number: K09-09814 UDI-DI code: 00884450215258 Lot Numbers: H2438008 H2606525 H2627174 H2649877 Catalog Number: K09-09900F UDI-DI code: 00884450550304 Lot Numbers: H2361545 H2367024 H2397842 H2418657 H2429846 H2439645 H2450863 H2496256 H2521372 H2558419 H2564300 H2573959 H2589897 H2602667 H2608718 H2619298 H2641101 H2729347 H2900324 H2911151 Catalog Number: K09-09902G UDI-DI code:00884450199497 Lot Numbers: H2367288 H2434574 H2714092 H2819618 Catalog Number: K09-09902GP UDI-DI code: 00884450225509 Lot Numbers: H2384769 H2400690 H2406480 H2419357 H2480746 H2506090 H2532707 H2569166 H2576723 H2740523 H2770409 H2787669 H2795430 H2813732 Catalog Number: K09-09975 UDI-DI code: 00884450227152 Lot Numbers: H2398797 H2475249 H2480024 H2747723 Catalog Number: K09-10060F UDI-DI code: 00884450199817 Lot Numbers: H2387220 H2408702 H2426184 H2442162 H2474639 H2487476 H2488262 H2532168 H2641733 H2667077 H2722249 H2740787 H2757842 H2780803 H2809448 H2831627 H2835536 H2837535 Catalog Number: K09-10062F UDI-DI code: 00884450258736 Lot Numbers: H2367042 H2382952 H2394414 H2397878 H2418715 H2430071 H2439675 H2464189 H2469939 H2490481 H2496132 H2500557 H2520079 H2520103 H2557540 H2582995 H2589885 H2612344 H2641142 H2693373 H2758490 H2782387 H2823926 H2841767 H2859915 H2875044 H2900293 Catalog Number: K09-10210A UDI-DI code: 00884450227404 Lot Numbers: H2389293 H2394402 H2397874 H2412352 H2418705 H2430061 H2439668 H2439669 H2450901 H2454881 H2476395 H2480731 H2490455 H2496128 H2500547 H2520065 H2520101 H2542768 H2557536 H2564320 H2569259 H2576634 H2594080 H2602692 H2603377 H2608728 H2612339 H2626745 H2626746 H2640668 H2641138 H2650751 H2663144 H2671726 H2687294 H2717944 H2758491 H2800041 Catalog Number: K09-10210B UDI-DI code: 00884450790731 Lot Numbers: H2808197 H2808201 H2813057 H2825050 H2842022 H2890149 H2910127 Catalog Number: K09-10286G UDI-DI code: 00884450572313 Lot Numbers: H2397843 H2418663 H2441779 H2510033 H2510034 H2542742 H2542743 H2569249 H2573960 H2614698 H2614775 H2641108 H2676779 H2701896 H2749383 H2758446 H2794933 H2823921 H2836597 H2854807 H2864894 H2905931 H2911152 H2920518 Catalog Number: K09-10300F UDI-DI code: 00884450621356 Lot Numbers: H2451653 H2451683 H2476488 H2496325 H2552833 H2565444 H2576950 H2582085 H2593408 H2626881 H2641355 H2725762 H2729014 H2767982 H2799977 H2814254 H2828175 H2836581 H2844891 H2854779 H2889676 H2899997 H2915459 Catalog Number: K09-10315B UDI-DI code: 00884450210017 Lot Numbers: H2406598 H2421161 H2440950 H2461487 H2471090 H2512356 H2599404 H2608319 H2627600 H2718395 H2757681 H2770542 Catalog Number: K09-10432A UDI-DI code: 00884450216590 Lot Numbers: H2585547 Catalog Number: K09-10444J UDI-DI code: 00884450540534 Lot Numbers: H2393387 H2405418 H2418744 H2420393 H2473593 H2473921 H2502889 H2520929 H2523472 H2559719 H2567730 H2581896 H2595423 H2615355 H2659761 H2714925 H2740828 H2753531 Catalog Number: K09-10475 UDI-DI code: 00884450224045 Lot Numbers: H2359867 H2434434 H2762982 H2879883 Catalog Number: K09-10494C UDI-DI code: 00884450750087 Lot Numbers: H2752403 H2770554 H2796720 H2875209 H2890040 H2905039 Catalog Number: K09-10574D UDI-DI code: 00884450273753 Lot Numbers: H2357365 H2367014 H2382869 H2382870 H2397959 H2412252 H2439630 H2439631 H2450808 H2469972 H2470758 H2476249 H2490404 H2510681 H2519993 H2542703 H2564290 H2569231 H2581941 H2608677 H2650689 H2650690 H2671713 H2687253 H2717893 H2736570 H2763408 H2782351 H2792530 H2828183 H2841750 H2854788 H2864812 H2869826 H2885367 H2889687 H2905909 H2915464 H2927604 Catalog Number: K09-10726 UDI-DI code: 00884450216866 Lot Numbers: H2757793 H2789161 H2837453 Catalog Number: K09-10736D UDI-DI code: 00884450624500 Lot Numbers: H2350713 H2381987 H2409953 H2431360 H2442130 H2474643 H2509836 H2520881 H2543653 H2559926 H2631423 Catalog Number: K09-10788A UDI-DI code: 00884450559963 Lot Numbers: H2369351 H2387652 H2409538 H2421237 H2471294 H2512353 Catalog Number: K09-10811 UDI-DI code: 00884450557716 Lot Numbers: H2356093 H2379951 H2406488 H2421298 H2436923 H2440967 H2471308 H2502997 H2525135 H2555403 H2578855 H2666884 H2714927 H2867112 Catalog Number: K09-10829B UDI-DI code: 00884450457917 Lot Numbers: H2393002 H2414040 H2443213 H2518372 H2536698 H2555947 H2575227 H2642119 H2659290 Catalog Number: K09-10830C UDI-DI code: 00884450210499 Lot Numbers: H2428294 H2489561 H2518331 H2575114 Catalog Number: K09-10929 UDI-DI code: 00884450217405 Lot Numbers: H2407687 H2432447 H2454272 H2475251 H2500493 H2529823 H2561933 H2592015 H2627014 H2630698 H2642132 H2649811 H2670835 H2675978 H2709341 H2723108 H2751032 H2753528 H2762291 H2771800 H2810123 H2832688 H2845902 H2875107 H2897827 H2918270 H2928681 Catalog Number: K09-10994D UDI-DI code: 00884450681152 Lot Numbers: H2751606 H2806061 H2837645 H2846075 H2850717 H2855751 H2866120 H2879966 Catalog Number: K09-11024DP UDI-DI code: 00884450262726 Lot Numbers: H2387198 H2413770 H2460764 H2488227 H2520830 H2583327 H2621133 H2653189 H2655274 H2676289 H2722100 H2743926 H2780763 H2813645 H2847029 H2859359 H2863998 H2890071 H2920682 Catalog Number: K09-11076C UDI-DI code: 00884450282410 Lot Numbers: H2745424 H2763296 H2833774 H2871335 Catalog Number: K09-11107D UDI-DI code: 00884450647103 Lot Numbers: H2399232 Catalog Number: K09-11149B UDI-DI code: 00884450549704 Lot Numbers: H2360513 H2382896 H2418656 H2450861 H2470766 H2476281 H2496277 H2500510 H2520032 H2603466 H2619297 H2641809 H2650721 Catalog Number: K09-11196 UDI-DI code: 00884450218082 Lot Numbers: H2359707 H2381003 H2414043 H2448741 H2474049 H2480103 H2518373 H2536699 H2551744 H2555948 H2600866 H2630752 H2649859 H2659267 H2665498 H2751651 H2751656 H2762130 H2781198 H2819491 H2832489 H2845472 H2866096 H2881356 Catalog Number: K09-11207DP UDI-DI code: 00884450224281 Lot Numbers: H2359229 H2406868 H2474265 H2518282 H2556087 H2585788 H2605796 H2630822 H2645018 H2659655 H2751112 H2812795 H2866049 H2867490 H2896918 Catalog Number: K09-11259G UDI-DI code: 00884450750933 Lot Numbers: H2758542 H2782425 H2840940 H2885430 H2915502 Catalog Number: K09-11259GP UDI-DI code: 00884450770740 Lot Numbers: H2796087 H2800045 H2809498 H2819135 Catalog Number: K09-11444B UDI-DI code: 00884450249994 Lot Numbers: H2387235 H2442241 H2487375 H2523476 H2532715 H2587844 H2615569 H2666885 H2740793 H2780835 H2804200 H2819620 H2853709 H2915355 H2932752 Catalog Number: K09-11482D UDI-DI code: 00884450334089 Lot Numbers: H2360602 H2387199 H2393370 H2413772 H2425986 H2446876 H2474651 H2488229 H2520863 H2543650 H2559873 H2595402 H2606689 H2659699 H2666909 H2713997 H2746403 H2774630 H2809410 Catalog Number: K09-11607B UDI-DI code: 00884450265451 Lot Numbers: H2409657 Catalog Number: K09-11646C UDI-DI code: 00884450210864 Lot Numbers: H2364084 H2391416 H2407700 H2423152 H2474140 H2500498 H2546015 H2567145 H2585556 H2627016 H2665582 H2685243 H2751517 H2860569 H2884403 Catalog Number: K09-11913C UDI-DI code: 00884450544488 Lot Numbers: H2387651 H2409536 H2471424 H2506105 H2520527 H2529745 Catalog Number: K09-12030AP UDI-DI code: 00884450632314 Lot Numbers: H2757856 H2780816 H2804118 H2831644 H2842002 H2867061 H2880114 H2910138 H2926565 H2933143 Catalog Number: K09-12245A UDI-DI code: 00884450261576 Lot Numbers: H2505776 H2523568 H2779968 Catalog Number: K09-12304A UDI-DI code: 00884450555750 Lot Numbers: H2454270 H2471307 H2506113 H2514525 H2544423 H2560083 H2578853 H2590004 H2608457 Catalog Number: K09-12304B UDI-DI code: 00884450743300 Lot Numbers: H2640829 H2702833 H2714919 H2770563 H2796743 H2835778 H2849848 H2866801 H2890049 H2910095 H2915560 H2920617 Catalog Number: K09-12359B UDI-DI code: 00884450273586 Lot Numbers: H2523510 H2615216 Catalog Number: K09-12396FP UDI-DI code: 00884450638736 Lot Numbers: H2360505 H2383032 H2418585 H2429836 H2439636 H2469988 H2490412 H2581950 H2592418 H2667624 H2676798 H2707272 H2749380 H2754014 H2792534 H2799992 H2814261 H2823906 H2828184 H2835136 H2841751 H2846814 H2864816 H2895264 H2905910 H2926208 H2933006 Catalog Number: K09-12404 UDI-DI code: 00884450258248 Lot Numbers: H2360546 H2382951 H2388004 H2418714 H2454885 H2464188 H2469938 H2480739 H2500553 H2520078 H2542782 H2557539 H2569263 H2602702 H2701886 H2749398 H2782390 H2800047 H2841769 H2854818 H2869868 H2889717 H2920545 Catalog Number: K09-12556B UDI-DI code: 00884450292679 Lot Numbers: H2520739 H2575311 H2617749S1 Catalog Number: K09-12615 UDI-DI code: 00884450290583 Lot Numbers: H2381996 H2399227 H2434608 H2453439 H2474393 H2493073 H2513076 H2528957 H2558248 H2569171 H2591932 H2608202 H2629346 H2666892 H2714934 H2740794 H2757880 H2789382 H2804209 H2819622 H2837614 H2847071 H2876247 H2890157 H2910104 Catalog Number: K09-12698 UDI-DI code: 00884450286579 Lot Numbers: H2356023 H2387224 H2477451 H2496748 H2506084 H2520912 H2576667 H2666951 H2714891 H2757846 H2837540 H2865612 Catalog Number: K09-12698A UDI-DI code: 00884450820858 Lot Numbers: H2890177 Catalog Number: K09-12699 UDI-DI code: 00884450298985 Lot Numbers: H2414045 H2437915 H2475377 H2509009 H2523550 H2569476 H2575229 Catalog Number: K09-12699A UDI-DI code: 00884450750551 Lot Numbers: H2666940 H2745973 Catalog Number: K09-12699B UDI-DI code: 00884450812587 Lot Numbers: H2850573 H2868386 Catalog Number: K09-12704A UDI-DI code: 00884450293072 Lot Numbers: H2367556 H2379948 H2392946 H2440958 H2454149 H2498353 H2539645 H2613546 H2641685 H2676870 H2718406 H2744318 H2757707 H2770548 H2809534 H2824866 H2833764 H2849844 H2875212 H2905048 Catalog Number: K09-12867A UDI-DI code: 00884450333723 Lot Numbers: H2791694 Catalog Number: K09-12899A UDI-DI code: 00884450584101 Lot Numbers: H2372599 H2473518 H2480643 H2488248 H2614539 H2666923 H2714964 H2804062 H2835783 H2853419 H2880059 H2915611 H2920697 Catalog Number: K09-12939B UDI-DI code: 00884450413388 Lot Numbers: H2367049 H2397879 H2430074 H2450931 H2454887 H2498359 H2520088 H2542795 H2557542 H2569270 H2589903 H2619313 H2641146 H2663149 H2687303 Catalog Number: K09-12939C UDI-DI code: 00884450783504 Lot Numbers: H2801465 H2864076 H2890160 Catalog Number: K09-13082C UDI-DI code: 00884450570364 Lot Numbers: H2361543 H2366906 H2388869 H2398090 H2429658 H2452058 H2460706 H2470705 H2476550 H2491185 H2497336 H2521411 H2558177 H2602290 H2602346 H2613415 H2626915 H2641627 H2687237 H2719321 H2725842 H2736545 H2749440 H2773117 H2792516 H2796069 H2810047 H2814238 H2828102 H2836572 H2841730 H2849092 H2854761 H2879366 H2889615 H2899954 Catalog Number: K09-13171 UDI-DI code: 00884450440025 Lot Numbers: H2448669 H2475262 H2480087 H2518337 H2567149 H2627027 H2665590 H2685152 H2735255 H2762303 H2800031 Catalog Number: K09-13228A UDI-DI code: 00884450645109 Lot Numbers: H2413524 H2417602 H2473995 H2501024 Catalog Number: K09-13337BP UDI-DI code: 00884450539910 Lot Numbers: H2356007 H2399172 H2418666 H2434227 H2471341 H2488236 H2493001 H2520873 H2572185 H2601392 H2617009 H2641408 H2659705 H2714837 H2714838 H2764448 H2780771 H2786377 H2804059 H2825006 H2838172 H2844559 H2867100 H2880062 H2890079 H2905176 Catalog Number: K09-13420 UDI-DI code: 00884450481073 Lot Numbers: H2434618 H2493078 H2567728 H2804212 Catalog Number: K09-13507CP UDI-DI code: 00884450634127 Lot Numbers: H2745953 H2764499 H2780782 H2818325 H2844562 H2853425 H2867097 H2875302 H2905191 H2910592 Catalog Number: K09-13617P UDI-DI code: 00884450621134 Lot Numbers: H2746377 H2761524 Catalog Number: K09-13659AP UDI-DI code: 00884450587508 Lot Numbers: H2749817 H2759126 H2770399 Catalog Number: K09-13660 UDI-DI code: 00884450558102 Lot Numbers: H2386167 H2413493 H2444246 H2448836 H2519357 H2537889 H2596113 H2709059 H2713404 H2753890 H2763003 H2776753 H2845999 H2879893 H2885127 H2912334 Catalog Number: K09-13767 UDI-DI code: 00884450603307 Lot Numbers: H2641154 H2642946 H2773381 H2804874 H2846834 H2869869 H2889718 H2915481 Catalog Number: K09-13880 UDI-DI code: 00884450732700 Lot Numbers: H2604628 H2641722 H2666966 H2796739 H2811122 H2821392 H2834318 H2880040 H2890051 H2915561 H2920619 Catalog Number: K09-13882 UDI-DI code: 00884450659700 Lot Numbers: H2370740 Catalog Number: K09-13882A UDI-DI code: 00884450720325 Lot Numbers: H2559933 H2752306 H2780792 H2831609 H2880069 H2905203 Catalog Number: K09-13933 UDI-DI code: 00884450666708 Lot Numbers: H2394993 H2408701 Catalog Number: K09-14000 UDI-DI code: 00884450749913 Lot Numbers: H2792573 Catalog Number: K09-14000A UDI-DI code: 00884450785102 Lot Numbers: H2800118 H2814953 H2854844 H2875095 Catalog Number: K09-14047 UDI-DI code: 00884450743317 Lot Numbers: H2749842 H2757828 H2825022 H2859396 H2895090 H2922539 Catalog Number: K09-14096 UDI-DI code: 00884450741993 Lot Numbers: H2625857 H2650759 H2758506 H2782391 H2823929 H2828209 H2841770 H2869870 H2885396 H2905939 H2915482 Catalog Number: K09-14196 UDI-DI code: 00884450806302 Lot Numbers: H2838189 Catalog Number: K09-14219 UDI-DI code: 00884450812709 Lot Numbers: H2850576 H2868384 H2920719 Catalog Number: K09-14220 UDI-DI code: 00884450813393 Lot Numbers: H2850578 H2868383 Catalog Number: K09T-13643 UDI-DI code: 00884450540329 Lot Numbers: T2428999 T2449676 T2466104 T2490332 T2550721 T2556890 T2606429 T2667831 T2697369 T2699398 T2699399 T2723025 T2753441 T2807106 T2842475 T2879925 T2895213 T2918330

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 9 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.

Z-2565-2024
Recall number
Z-2565-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
138471

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: K10-01722QP 00884450570340 H2410331 H2471342 H2480639 H2502357 H2513044 H2525139 H2543652 H2558245 H2564522 H2825008 H2831600 H2875331 H2915643 K10-03220AP 00884450174036 H2406448 H2408885 H2423250 H2428461 H2448942 H2500653 H2536816 H2567302 H2601107 H2623288 H2659637 H2665379 H2708979 H2721135 H2730471 H2760266 H2774855 H2794124 H2812819 H2829027 H2838364 H2843344 H2850151 H2868190 H2872165 H2905227 H2913401 K10-03591KP 00884450380635 H2391366 H2408970 H2441713 H2472906 H2482293 H2491990 H2496930 H2500665 H2518450 H2527822 H2551825 H2567305 H2627298 H2638378 H2645033 H2708977 H2716700 H2730479 H2751466 H2778878 H2784096 H2794135 H2808194 H2821498 H2918877 K10-04291AP 00884450176320 H2352552 H2401233 H2418439 H2431501 H2461658 H2475592 H2492022 H2511077 H2513895 H2518283 H2530047 H2538940 H2551884 H2563710 H2567356 H2641969 H2662164 H2679955 H2713607 H2728230 H2744412 H2785947 H2795948 H2809437 H2818171 H2832163 H2843600 H2866062 H2896827 H2912839 H2918929 K10-04386CP 00884450197523 H2384157 H2401236 H2423252 H2444355 H2470464 H2496947 H2522107 H2559517 H2573434 H2655272 H2659665 H2665397 H2708975 H2730487 H2744361 H2746709 H2755852 H2778887 H2834781 H2838372 H2844785 H2872168 H2882630 H2897046 H2913305 H2918921 K10-04429 00884450176795 H2418279 H2448704 H2468945 H2489657 H2505650 H2518225 H2585617 H2600807 H2642069 H2642462 H2665625 H2692001 H2703157 H2728629 H2735292 H2756121 H2776259 H2795556 H2814363 H2832784 H2845927 H2875164 H2913298 H2928657 K10-04479P 00884450177075 H2409371 H2475562 K10-04722C 00884450270431 H2429014 H2496323 H2520764 H2557465 H2589898 H2626879 H2666564 H2736535 H2777762 H2799974 H2828177 H2859884 H2864805 H2905908 K10-04931B 00884450393147 H2402920 H2469836 H2474257 H2476022 H2480793 H2494885 H2751615 H2782208 H2787882 H2800804 H2815006 H2824607 H2871355 K10-05043A 00884450202074 H2610631 H2627090 H2680755 H2728653 H2875168 H2928687 K10-05120P 00884450197202 H2399127 H2431312 H2498451 H2523383 H2527704 H2553771 H2576585 H2655265 H2669130 H2720156 H2757798 H2831587 H2837463 H2847025 H2867088 H2890107 H2915648 H2920730 K10-05222 00884450230824 H2839171 H2849535 K10-05251AP 00884450265499 H2408968 H2428471 H2448946 H2469092 H2475567 H2562411 H2567311 H2585822 H2627308 H2633766 H2655299 H2665378 H2675063 H2708968 H2744380 H2755857 H2774890 H2784101 H2789811 H2802599 H2829053 H2843351 H2877200 H2891663 H2928416 K10-05530 00884450284407 H2581869 K10-06011AP 00884450634516 H2752358 H2771050 H2818172 H2849571 H2866057 K10-06012P 00884450681107 H2464776 H2507506 H2507672 H2518503 H2576565 H2585848 H2641118 H2650735 H2707287 H2763420 H2900287 H2915472 K10-06033AP 00884450663707 H2780818 H2804119 H2816921 H2831647 H2837566 H2867095 H2890128 H2910148 K10-06066 00884450695524 H2744543 H2824018 H2869593 H2884336 H2912589 K10-06086P 00884450695111 H2804075 H2813661 H2831607 H2867102 K10T-05227 00884450619957 T2736090 T2842237 T2862543 T2899709 K10T-05815 00884450486061 T2143908 T2310781 T2323193 T2330789 T2340443 T2363413 T2363416 T2414967 T2427552 T2437298 T2474307 T2534990 T2534991 T2576721 T2580922S K10T-05816 00884450486115 T2198303 T2237161 T2238504 T2259632 T2259636 T2259646 T2323194 T2330794 T2330795 T2330796 T2363411 T2363412 T2363417 T2370536 T2399814 T2417139 T2427554 T2427562 T2456678 T2469555 T2474316 T2474987 T2474987S T2534987 T2534988 T2542105 T2553454 T2553455 T2553457 T2580725S T2590403 T2626099 K10-00592K 00884450235140 H2393452 H2420172 H2443412 H2451992 H2470701 H2476538 H2521149 H2521296 H2544998 H2577007 H2613404 H2642940 H2697212 H2707453 H2744182 H2763384 H2792508 H2846785 H2850808 H2864775 H2911026 K10-00777BP 00884450171356 H2382837 H2412350 H2412351 H2439664 H2454880 H2469915 H2496127 H2521359 H2532904 H2549693 H2564318 H2608724 H2630383 H2671723 H2676769 H2681498 H2729338 H2744246 H2782393 H2796088 H2800051 H2823930 H2828210 H2900295 H2908480 H2928030 K10-00785LP 00884450171363 H2354646 H2359761 H2381074 H2500634 H2576482 H2592743 H2633681 H2746688 H2829020 K10-00814L 00884450375211 H2391149 H2429178 H2429179 H2474142 H2519369 H2702874 H2709084 H2729408 H2865738 H2912314 H2932289 K10-00839FP 00884450171509 H2353207 H2442209 H2474355 H2559946 H2582189 H2666829 H2703436 H2730574 H2770405 H2777617 H2795425 H2819611 H2828354 H2847065 H2853704 H2859507 H2905308 K10-01270T 00884450320792 H2406427 H2413487 H2480743 H2519372 H2585454 H2596107 H2600560 H2615014 H2705266 H2717708 H2729411 H2753894 H2767717 H2781958 H2805418 H2824729 H2846005 H2879898 H2885139 K10-01571C 00884450172704 H2437814 H2469804 H2475959 H2519374 H2537897 H2562540 H2585455 H2591201 H2607153 H2705250 H2713444 H2738386 H2749188 H2767718 H2781960 H2800719 H2828298 H2865687 H2912221 H2927507 K10-01700AP 00884450172896 H2432646 H2475553 H2513924 H2518194 H2523106 H2546141 H2627293 H2633685 H2684906 H2755834 H2760262 H2789795 H2802581 H2834774 H2850144 H2896990 K10-03184 00884450173978 H2723085 K10-03290D 00884450174173 H2398057 H2429642 H2440121 H2470702 H2476533 H2497323 H2521293 H2552981 H2569338 H2593800 H2602335 H2626906 H2657735 H2736546 H2758364 H2767991 K10-03327D 00884450358474 H2399047 H2475961 H2490868 H2500928 H2642098 H2699127 H2763063 H2772973 H2781982 H2805423 H2814903 H2866206 H2916581 K10-03364A 00884450174302 H2767140 H2787066 H2825503 K10-03383BP 00884450174470 H2413766 H2431314 H2442065 H2451601 H2480561 H2531173 H2543647 H2559858 H2678789 H2690630 H2729477 H2746472 H2780753 H2802285 H2818310 H2847026 H2870440 H2895058 K10-03666B 00884450175088 H2823758 K10-04183CP 00884450176054 H2351711 H2354650 H2432649 H2469087 H2530021 H2556100 H2576500 H2596269 H2615644 H2669945 H2675061 H2680064 H2721140 H2746703 H2755848 H2765532 H2778883 H2798349 H2838371 H2844086 H2857414 H2882625 H2897043 H2905266 H2912943 H2928402 K10-04201GP 00884450431429 H2381217 H2405971 H2453053 H2474162 H2482360 H2488359 H2500676 H2516291 H2517062 H2544212 H2549177 H2551826 K10-04360B 00884450176511 H2402908 H2434453 H2454179 H2475964 H2500929 H2519386 H2537904 H2550456 H2562543 H2591207 H2625331 H2658559 H2709092 H2713458 H2724386 H2738402 H2743422 H2758297 H2767724 H2772976 H2781983 H2787737 H2796458 H2800724 H2814909 H2824736 H2837110 H2857775 H2885153 H2912269 H2916582 K10-04413A 00884450176740 H2386135 H2412595 H2417532 H2470430 H2575472 H2591208 H2607155 H2615025 H2642082 H2653570 H2705208 H2814913 H2866220 K10-04426B 00884450435441 H2413490 H2448841 H2475965 H2519387 H2537905 H2566457 H2630955 H2709095 K10-04621 00884450177457 H2406989 H2413470 H2444262 H2475966 H2511862 H2519388 H2684812 H2709283 H2713461 H2824738 H2837113 H2860555 H2871428 H2893756 H2915982 K10-04693D 00884450262481 H2407705 H2428330 H2464965 H2475323 H2518222 H2551727 H2596200 H2627088 H2703135 H2747760 H2787067 H2800132 H2814364 H2869637 K10-04800DP 00884450196021 H2488218 H2520856 H2595396 H2614413 H2641388 H2655270 H2690568 H2708832 H2720157 H2764416 H2777638 H2795332 H2809399 H2824993 H2838132 H2844551 H2859356 H2867094 H2880073 H2890106 H2910624 K10-05097A 00884450197073 H2386175 H2448851 H2519426 H2575499 H2607205 H2633708 H2654764 K10-05097B 00884450756508 H2685180 H2781343 H2837271 H2849973 H2866212 H2913308 K10-05274AP 00884450659519 H2587850 H2655380 H2666828 H2720256 H2745963 H2770428 H2780848 H2789392 H2813743 H2842017 H2875374 H2899222 H2905310 H2921244 K10-05343 00884450235560 H2529935 H2555969 H2592259 H2600916 H2675783 H2685118 H2703568 H2735167 H2762172 H2781243 H2795447 H2819538 H2881378 K10-05457AP 00884450312780 H2746387 H2764528 H2813694 H2831628 H2837542 H2841993 H2844694 H2867091 H2875345 H2890127 H2899252 K10-05472 00884450270639 H2409929 H2413270 H2498456 H2559869 H2641711 K10-05511 00884450283646 H2448561 K10-05636A 00884450394014 H2391156 H2397178 H2424068 H2448843 H2490871 H2585460 H2615031 H2749195 H2767728 K10-05675 00884450400944 H2753581 H2837273 K10-05700 00884450466759 H2744209 H2753582 H2791763 H2800136 H2814373 H2828011 H2837274 H2849975 H2875169 K10-05774P 00884450555910 H2402965 H2414102 H2500788 H2564127 H2592795 H2675065 H2684903 H2721147 H2739358 H2746717 H2770024 H2843360 H2868179 H2877212 H2913283 K10-05833P 00884450552957 H2751209 K10-05913P 00884450522356 H2418662 H2442106 H2453336 H2488235 H2498463 H2528155 H2547566 H2576600 H2581874 H2636097 K10T-00856B 00884450257630 T2131617 T2194472 T2239571 T2268933 T2310883 T2329171 T2360494 T2417861 T2465749 T2479569 T2505793 T2527123 T2587256 T2596741 T2652615 T2698965 T2712047 T2786089 T2805471 T2840601 T2842270 T2862040 T2898698 K10T-01343F 00884450238516 T2700152 T2712393 T2741709 T2775305 T2805997 T2848063 T2872006 T2885311 K10T-03849G 00884450201459 T2256824 T2299853 T2322984 T2333571 T2355740 T2387061 T2407485 T2429021 T2437094 T2499082 T2521173 T2527253 T2550792 T2572078 T2610045 T2655959 T2677529 T2701730 T2727027 T2761356 T2807112 T2832505 T2869837 T2910727 K10T-03903F 00884450257593 T2587257 T2625819 T2652624 T2708973 K10T-03958L 00884450414910 T2167604 T2261967 T2305936 T2322986 T2340254 T2370031 T2404523 T2429022 T2446367 T2470234 T2505381 T2509730 T2527260 T2536900 T2609506 T2670069 T2745524 T2760426 T2775349 T2830814 T2864822 T2899047 K10T-03997F 00884450447017 T2662074 K10T-04110B 00884450320624 T2363588 T2382425 T2457932 T2479583 T2498833 T2536906 T2581366 T2625820 T2677550 T2746584 T2752959 T2801981 T2863415 K10T-04155C 00884450267554 T2643976 K10T-04216G 00884450240878 T2360553 T2397204 T2412578 T2449689 T2494475 T2527503 T2550727 T2587447 T2627403 T2680829 T2713192 T2750452 T2758255 T2818275 T2862473 T2877074 T2918375 K10T-04278C 00884450318836 T2360557 T2397183 T2527527S T2550628 T2620405 T2747270 T2761384 T2816472 T2824136 T2928269 K10T-04335A 00884450413852 T2732959 T2762843 T2921111 K10T-04662A 00884450306109 T2283344 T2306126 T2330944 T2352352 T2371538 T2404616 T2489387 T2537750 T2543102 T2570353 T2609818 T2658520 T2682252 T2740099 T2773384 T2779965 T2792493 T2816379 T2843421 T2862488 T2906192 T2918402 K10T-04942A 00884450319659 T2351570 T2366382 T2397184 T2429120 T2443500 T2465880 T2499019 T2499664 T2515748 T2521872 T2527598 T2581434 T2595447 T2606462 T2643847 T2680804 T2773330 T2779967 T2816321 T2833110 T2902199 T2906195 T2927195 K10T-04978H 00884450501245 T2626084 T2709021 T2750457 T2816449 T2848391 T2849852 T2905868 K10T-05139 00884450388495 T2604766 K10T-05261 00884450320297 T2408189 T2417985 T2446370 T2479737 T2637165 T2736369 T2781930 T2821650 T2848452 T2870228 T2884484 T2898771 T2927200 K10T-05403 00884450247235 T2485404 T2527717 T2584669 T2670915 T2754726 T2833118 T2899048 K10T-05428 00884450264195 T2339967 T2371539 T2383202 T2404674 T2427545 T2434463 T2458517 T2516379 T2527722 T2578263 T2587584 T2609819 T2644043 T2680608 T2701830 T2718892 T2750466 T2775548 T2823560 T2827728 T2848575 T2862546 T2902677 T2906263 T2921192 K10T-05668D 00884450486702 T2256883 T2310963 T2333977 T2355746 T2399998 T2404953 T2429306 T2498021 T2499043 T2511779 T2550738 T2572042 T2606490 T2643781 T2670926 T2699281 T2738156 T2774643 T2775584 T2800622 T2827649 T2842495 T2862612 T2898777 T2902696 T2918477 K12-05018 00884450193778 H2428338 H2615366 H2753586 H2800139 H2857780

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 10 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures.

Z-2566-2024
Recall number
Z-2566-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
69 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: K11-00382C 00884450158425 H2379628 H2531736 H2536619 H2813488 H2881603 H2916468

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 11 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.

Z-2567-2024
Recall number
Z-2567-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
34197 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: K12-02097B 00884450191309 H2413516 H2430266 H2448853 H2474037 H2505248 H2518159 H2540340 H2545409 H2575507 H2591235 H2744213 H2751673 H2846090 H2879948 H2912178 K12-02489A 00884450191422 H2407774 H2413469 H2520693 H2550452 H2566464 H2607157 H2705182 H2753896 H2758300 H2814926 H2850642 K12-03447 00884450192443 H2404130 H2408589 H2439003 H2451626 H2690274 H2757182 H2817430 H2846659 K12-03846 00884450144848 H2472033 H2494636 H2507902 H2536621 H2552837 H2557081 H2718140 H2810887 K12-04185A 00884450193143 H2398739 H2418369 H2557282 H2595087 H2635991 H2666462 H2690318 H2719739 H2775079 H2780258 H2792424 H2881789 H2916471 K12-04262BP 00884450250426 H2760748 H2784117 H2802626 H2829046 H2877237 H2897143 H2913395 K12-09098C 00884450816509 H2912500 H2912511 H2912512 H2912513 K12-10056 00884450383704 H2406238 H2418284 H2437885 H2469808 H2518359 H2529863 H2541614 H2555920 H2592114 H2659218 H2685221 H2709291 H2741843 H2767146 H2781349 H2795585 H2827702 H2845945 H2866232 H2875176 H2898026 K12-11132B 00884450746530 H2756363 H2762177 H2781251 H2818304 H2832627 H2866135 H2884335 H2931204 K12-12079P 00884450652503 H2760347 H2770070 H2778943 H2798363 H2808227 H2825288 H2838422 H2857759 H2867574 H2897171 H2905369 H2913161 K12-12192P 00884450696118 H2879420 H2885386 K12-12335 00884450716328 H2562551 H2591862 H2607163 H2615042 H2649774 H2705172 H2751359 H2763152 H2772980 H2810502 H2866204 H2871433 H2912338 K12-12382 00884450767702 H2819681 K12M-02489 00884450092873 H2405222 H2520692 H2800145 K12-00443A 00884450190647 H2757679 H2778135 H2796711 H2866277 H2905075 H2915547 H2926391 K12-00657A 00884450190722 H2535655 H2795577 H2810190 K12-01348D 00884450190975 H2383033 H2418832 H2436858 H2451479 H2495639 H2516727 H2520753 H2550062 H2557408 H2599531 H2729229 H2782335 H2836580 H2879389 K12-02111 00884450400517 T2616733 T2653219 T2709061 T2752964 T2821654 T2862633 T2899120 T2932790 K12-02112 00884450400524 T2587406 T2596839 T2653221 T2688030 T2718647 T2733013 T2775588 T2802964 T2827652 T2842314 T2899023 K12-03438 00884450192412 H2418283 H2489665 H2572196 H2659563 H2675954 H2747768 H2866235 H2881466 K12-05494 00884450194133 H2764836 H2817505 H2828814 H2844859 K12-05576G 00884450394816 T2489238 T2489238S T2498868 T2616734 T2625824 T2740284 T2758288 T2779743 T2792619 T2816292 T2849694 T2906286 K12-05805A 00884450391051 T2232844 T2290430 T2329711 T2360690 T2427593 T2458542 T2499085 T2511362 T2555156 T2587519 T2627492 T2670933 T2699182 T2738197 T2802974 T2849863 T2902775 T2919721 K12-06318 00884450161821 H2399243 H2405752 H2421061 H2440852 H2473607 H2495222 H2518737 H2518738 H2553249 H2629602 H2652655 H2685033 H2704237 H2714593 H2736618 H2756210 H2782550 H2792325 H2820346 H2848446 H2869766 H2873395 H2897239 K12-06509A 00884450546925 H2760798 H2760799 H2799936 H2827918 H2832624 H2845494 H2881391 K12-06509B 00884450831151 H2925180 H2925184 K12-07208A 00884450234372 H2423209 H2428435 H2476040 H2585526 H2625403 H2654836 H2705056 H2824534 H2833789 H2885273 K12-07299P 00884450205051 H2765572 H2770055 H2774920 H2789836 H2808226 H2834790 H2838415 H2850204 H2882653 H2891703 H2897156 H2913008 K12-08303 00884450259290 H2765793 H2786648 H2795405 H2825027 H2837539 H2859419 H2890129 H2899255 H2915703 K12-08716 00884450281611 H2489883 H2512815 H2529971 H2575336 H2585770 H2615571 H2849684 K12-09009 00884450278048 H2625375 H2741745 H2743438 H2749202 H2758304 H2767731 H2866221 H2904508 H2927568 K12-10375 00884450410257 H2740385 H2757742 H2783289 H2796737 H2824894 H2849850 K12-10914 00884450443927 H2757139 H2763456 H2788121 H2796775 H2803156 K12-10962 00884450459850 H2757850 H2844695 H2859430 H2915384 K12-11131AP 00884450554944 H2760338 H2770059 H2787186 H2794192 H2812899 H2838417 H2850211 H2866043 H2886332 H2897168 K12-11133 00884450476055 H2787945 H2817450 H2844021 K12-11426 00884450500187 H2396335 H2414054 H2418341 H2448761 H2465110 H2494088 H2518207 H2541674 H2575288 H2585737 H2600923 H2606522 H2685059 H2741742 H2762178 H2791589 H2827919 K12-11669AP 00884450575956 H2493003 H2525138 H2567746 H2606696 H2614537 H2648576 H2655286 H2690603 H2714879 H2720165 H2764453 H2780779 H2825009 H2831601 H2841971 H2905224 K12-11821 00884450567012 H2390923 K12-11821P 00884450569801 H2386248 H2406446 H2414114 H2423279 H2633830 H2665313 H2669960 H2680037 H2713967 H2774923 H2838420 H2850214 H2866256 H2918807 K12-12053 00884450613108 H2408722 H2421065 H2440872 H2447205 H2477642 H2497438 H2509096 H2518743 H2539421 H2547208 H2564387 H2589607 H2616609 H2626428 H2652660 H2673425 H2685041 H2704238 H2743356 H2756216 H2770510 H2792316 H2810898 H2828819 H2833610 H2855826 H2866849 H2880085 H2907333 H2926243 H2931778 K12-12147 00884450644706 H2457285 H2475865 H2518744 H2518745 H2589613 H2601419 H2616349 H2626437 H2640599 H2658613 H2685045 H2704239 H2743357 H2756219 H2782555 H2828820 H2844895 H2855828 H2860747 H2866850 H2897241 K12T-10313C 00884450558911 T2310434 T2367456 T2534496 T2547548 T2587736 T2693219 T2816291 T2879933

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 12 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-02309 K12T-02392A K12T-02416 K12T-02510N K12T-02725G K12T-02725H K12T-02890K K12T-02949A K12T-03012C K12T-03014B K12T-03058A K12T-03139 K12T-03203F K12T-03319 K12T-03321F K12T-03515 K12T-03560D K12T-03566H K12T-03638H K12T-03706A K12T-03746C K12T-03788 K12T-03839H K12T-03853C K12T-03866B K12T-03867A K12T-03868 K12T-03868A K12T-04068 K12T-04106D K12T-04106F K12T-04140J K12T-04586D K12T-04697 K12T-04959B K12T-04963A K12T-05061J K12T-05081D K12T-05093D K12T-05281C K12T-05334D K12T-05423G K12T-05442B K12T-05472H K12T-05559B K12T-05824G K12T-05824H K12T-05825H K12T-05926C K12T-05991A K12T-06033C K12T-06211B K12T-06250 K12T-06282 K12T-06374D K12T-06416A K12T-06561A K12T-06640C K12T-06732A K12T-06783B K12T-06819C K12T-06979B K12T-07003A K12T-07008G K12T-07088 K12T-07266A K12T-07305 K12T-07556C K12T-07614A K12T-07729A K12T-07845B K12T-07893B K12T-08003 K12T-08565A K12T-08614B K12T-08727B K12T-08801 K12T-08867 K12T-09267D K12T-09337A K12T-09438A K12T-09523A K12T-09595 K12T-09685 K12T-09875 K12T-09880A K12T-09889 K12T-09974A K12T-10167A K12T-10287 K12T-10338H K12T-10409 K12T-10733 K12T-11467 K12T-11524A K12T-12152A K12T-12456 K22C-00001 K22C-00001A K22C-00034 K22C-00035 K22C-00042 K22C-00043 K22C-00052 K22C-00053A K22C-00054A K22C-00056 K22C-00058A K22C-00059 K22C-00062A K22C-00064A K22C-00069 K22C-00069A K22C-00070 K22C-11010 To support various vascular or cardiac diagnostic and interventional procedures.

Z-2568-2024
Recall number
Z-2568-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
103369 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: K09T-11796F 00884450503508 T2636554 K12T-01558G 00884450352670 T2329177 T2350727 T2371542 T2406796 T2430055 T2485419 T2540319 T2558850 T2574369 T2596749 T2637263 T2659470 T2716683 K12T-01558H 00884450782934 T2779744 T2823401 T2865508 T2909943 K12T-01822 00884450048849 T2329672 T2351649 T2366410 T2418145 T2479954 T2525431 T2544260 T2571995 T2635756 T2670966 T2716684 T2721174 T2738158 T2753461 T2781018 T2827635 K12T-01852L 00884450390641 T2627432 K12T-02006J 00884450410912 T2803003 T2866385 T2872131 K12T-02054 00884450048917 T2311048 T2323911 T2380682 T2383287 T2395389 T2427758 T2449372 T2464344 T2550262 T2609831 T2626139 T2697324 T2718897 T2753113 T2806098 T2832182 T2844200 T2866387 T2885324 K12T-02091G 00884450265925 T2458700 T2545242 T2587424 T2715273 T2736377 T2753117 T2780031 T2821698 T2888650 T2918566 K12T-02102B 00884450352861 T2597046 T2637278 T2662098 T2697333 T2751272 T2844211 K12T-02309 00884450055007 T2222971 T2331208 T2339980 T2405330 T2528876 T2560752 T2606584 T2697350 T2761529 T2821644 T2902935 K12T-02392A 00884450242926 T2144921 T2218464 T2244482 T2262003 T2296102 T2314800 T2339899 T2360807 T2416467 T2465735 T2509991 T2587265 T2637343 T2702608 T2776001 T2803012 T2821648 T2899061 K12T-02416 00884450238684 T2232553 K12T-02510N 00884450558522 T2616294 T2644061 T2776005 T2816289 T2886448 K12T-02725G 00884450278260 T2194607 T2303611 T2351004 T2408869 K12T-02725H 00884450679500 T2489997 T2587462 T2614079 T2655947 T2700183 T2713211 T2761550 T2781048 T2807148 T2906805 K12T-02890K 00884450242209 T2475031 T2570328 T2605749 T2626141 T2677852 T2704266 T2780036 T2803017 T2821647 T2823617 T2900194 K12T-02949A 00884450049211 T2449187 T2643784 K12T-03012C 00884450518328 T2232391 T2271357 T2305988 T2430292 T2540019 T2549960 T2560554 T2710204 T2776052 T2805520 K12T-03014B 00884450518533 T2193400 T2262009 T2283036 T2329184 T2428130 T2470356 T2540243 T2549961 T2560555 T2605751 T2697359 T2718786 T2805521 T2817191 T2899049 K12T-03058A 00884450339459 T2300687 T2352743 T2395547 T2428132 T2458769 T2544394 T2606612 T2776053 K12T-03139 00884450353073 T2300708 T2408265 T2635768 T2703042 T2776055 K12T-03203F 00884450267486 T2269004 T2306143 T2417470 T2428136 T2479772 T2489975 T2644066 T2712913 T2718901 T2776081 T2806122 T2857395 T2866400 K12T-03319 00884450353134 T2359607 T2410114 T2507033 T2555177 T2617479 T2677938 T2806125 K12T-03321F 00884450339749 T2560565 T2805523 K12T-03515 00884450340004 T2346209 T2397238 T2458796 T2521166 T2545225 T2567501 T2606688 T2697349 T2728037 T2790684 T2834451 T2898856 K12T-03560D 00884450275887 T2577403 T2596853 T2643858 T2671300 T2697352 T2747386 T2776197 T2787641 T2793976 T2804983 T2830191 T2850900 T2903192 K12T-03566H 00884450389379 T2537241 T2600430 K12T-03638H 00884450311929 T2585651 T2596114 T2627473 T2677948 T2721179 T2741661 T2803046 T2818681 T2867227 T2933583 K12T-03706A 00884450389416 T2407423 T2492158 T2529724 T2571996 T2678885 T2740350 T2818683 T2912461 K12T-03746C 00884450632130 T2299496 T2339989 T2379382 T2402602 T2444122 T2490003 T2529732 T2545239 T2550282 T2571766 T2587602 T2626205 T2650483 T2697347 T2703287 T2718916 T2755764 T2780054 T2844782 T2850911 T2899013 K12T-03788 00884450340394 T2291263 T2449755 T2670724 T2715275 T2759267 K12T-03839H 00884450282175 T2314982 T2355772 T2408277 T2408891 T2430362 T2449461 T2489612 T2540315 T2550286 T2606738 T2619210 T2662153 T2776015 T2818120 T2818722 T2912456 K12T-03853C 00884450285442 T2314812 T2334574 T2406905 T2458811 T2465287 T2489979 T2510099 T2537718 T2540755 T2560567 T2585658 T2605755 T2630606 T2678892 T2710699 T2762750 T2818286 T2823424 T2868316 K12T-03866B 00884450340622 T2128784 T2160422 T2167696 T2246023 T2290471 T2314813 T2385073 T2417877 T2458815 T2499604 T2509798 T2567527 T2609552 T2678902 T2712059 T2779760 T2855784 T2903282 K12T-03867A 00884450340639 T2670725 K12T-03868 00884450389508 T2203856 T2248929 T2280760 T2305998 T2329188 T2444194 T2489260 T2585659 T2609553 T2624426 T2656044 T2698981 K12T-03868A 00884450782941 T2805563 T2849953 T2881577 T2899752 K12T-04068 00884450341070 T2141096 T2194821 T2306290 T2329659 T2360968 T2407254 T2428274 T2489977 T2491591 T2529768 T2545303 T2570271 T2607282 T2643862 K12T-04106D 00884450277096 T2223561 T2254305 T2269068 T2306292 T2327725 T2405834 T2428275 T2465918 T2485444 T2543106 T2567613 T2577453 T2587427 T2596180 T2610031 T2643863 T2790774 T2806206 T2818804 T2832338 K12T-04106F 00884450801710 T2896964 K12T-04140J 00884450275252 T2540750 T2552597 T2609848 T2741650 T2780060 K12T-04586D 00884450332313 T2220947 T2281688 T2300710 T2324379 T2408318 T2545360 T2567749 T2619319 T2653469 T2753590 T2776266 T2803594 T2845126 T2896979 K12T-04697 00884450342589 T2246182 T2408910 T2466059 T2503562 T2582343 T2680636 T2736394 T2803599 T2806219 T2891669 T2928029 K12T-04959B 00884450252086 T2609855 T2662181 T2762879 T2796660 T2900208 K12T-04963A 00884450702109 T2806227 T2841694 K12T-05061J 00884450257173 T2216182 T2223508 T2262161 T2410189 T2485448 T2519282 T2560764 T2726152 T2783976 T2899063 K12T-05081D 00884450267967 T2511781 T2545907 T2736402 T2806237 T2851045 T2899113 K12T-05093D 00884450310830 T2240520 T2241107 T2303710 T2335756 T2410203 T2459150 T2470607 T2555869 T2591505 T2671532 T2752057 T2801086 K12T-05281C 00884450279021 T2306296 T2407255 T2459161 T2531086 T2550653 T2627324 T2712935 T2834914 T2928080 K12T-05334D 00884450287019 T2609862 T2697191 T2712937 T2753147 T2819184 T2899058 K12T-05423G 00884450600917 T2299509 T2401835 T2428492 T2459192 T2489504 T2516383 T2545965 K12T-05442B 00884450344644 T2383177 T2531497 T2545446 T2560767 T2587619 T2631576 T2712941 T2758378 T2786094 T2828836 T2866775 T2898958 K12T-05472H 00884450389911 T2246035 T2314835 T2346704 T2383560 T2422348 T2449273 T2596942 T2643373 T2654342 T2656058 T2795238 T2805644 T2832012 T2907036 K12T-05559B 00884450257180 T2591879 T2609869 T2660527 T2690364 T2712951 T2784197 T2823648 T2851072 T2872268 T2897146 T2928207 K12T-05824G 00884450393543 T2241113 T2246043 T2306056 T2346894 T2409203 T2425896 K12T-05824H 00884450679104 T2434270 T2517983 T2545130 T2545131 T2587313 T2619589 T2624401 T2650813 T2656065 T2684323 T2704362 T2713412 T2748324 T2762769 T2779796 T2803972 T2842373 T2849540 T2872271 T2897661 K12T-05825H 00884450394199 T2241114 T2260084 T2273671 T2346895 T2409206 T2445481 T2445482 T2545990 T2580012 T2596950 T2654363 T2712082 T2762770 T2791266 T2832022 T2842294 T2865657 T2910015 K12T-05926C 00884450285183 T2246191 T2306176 T2325394 T2351048 T2484538 T2543074 T2712963 T2806285 K12T-05991A 00884450346792 T2216249 T2246192 T2297808 T2323705 T2358814 T2385300 T2418030 T2438761 T2484557 T2532120 T2570326 T2608879 T2626232 T2679155 T2752202 T2791366 T2830812 T2904810 K12T-06033C 00884450356821 T2380321 T2552693 T2560408 T2587631 T2611542 T2710250 T2716734 T2777468 T2800763 T2814337 T2832384 T2851125 T2883799 T2928229 K12T-06211B 00884450354711 T2422372 T2445623 T2505116 T2532300 T2571635 T2609883 T2644137 T2679173 T2712996 T2736412 T2756084 T2786078 T2806292 T2882708 T2904827 K12T-06250 00884450354797 T2238159 K12T-06282 00884450160817 T2371879 T2409217 T2489567 T2519311 T2527059 T2580048 T2697361 T2741637 T2819387 T2851133 K12T-06374D 00884450570357 T2385099 T2422413 T2459226 T2532306 T2570256 T2596954 T2656069 T2690322 T2736260 T2804776 T2830037 K12T-06416A 00884450355046 T2232765 T2431680 T2485384 T2568711 K12T-06561A 00884450207000 T2329249 T2422954 T2465726 T2557907 K12T-06640C 00884450243251 T2329484 T2485380 T2550384 T2580090 T2680666 T2713000 T2746752 T2823657 K12T-06732A 00884450309193 T2632144 K12T-06783B 00884450355190 T2206927 T2235660 T2297962 T2312071 T2393079 T2417245 T2442973 T2469346 T2532378 T2552697 T2560796 T2609902 T2644143 T2704829 T2736416 T2784324 T2816470 T2830076 T2876323 K12T-06819C 00884450388594 T2550389 T2596244 T2609903 T2610665 T2644145 T2662204 T2713003 T2714802 T2748394 T2776740 T2787638 T2803443 T2819855 T2823659 T2845734 T2851137 T2900328 T2900329 K12T-06979B 00884450286661 T2407257 T2445800 T2505304 T2546243 T2550662 T2568730 T2582612 T2627332 T2643867 T2684403 T2753172 T2814329 T2838972 T2851143 K12T-07003A 00884450299111 T2206930 T2240580 T2262043 T2304690 T2314852 T2347978 T2396533 T2417910 T2439326 T2465799 T2505838 T2532454 T2568732 T2587327 T2656073 T2699016 T2762773 T2804925 T2805675 T2903826 K12T-07008G 00884450501580 T2435094 T2479987 T2543251 T2580974 T2611539 T2632199 T2671820 T2742905 T2777536 T2821670 T2904994 K12T-07088 00884450199480 T2262044 T2325700 T2445821 T2487164 T2487165 T2569654 T2643387 T2729339 T2762774 T2804926 T2819554 T2859044 K12T-07266A 00884450294413 T2261979 T2314773 T2406773 T2449220 T2546276 T2587236 T2625755 T2712019 T2805396 T2849478 K12T-07305 00884450351529 T2169370 T2306180 T2409279 T2476700 T2571637 T2662209 T2894202 K12T-07556C 00884450630327 T2299526 T2315027 T2337374 T2402607 T2431728 T2466028 T2489598 T2532514 T2568773 T2587647 T2632269 T2672075 T2773328 T2806844 T2845762 T2866951 T2915841 K12T-07614A 00884450309308 T2390018 T2407154 T2410169 T2532515 T2560820 T2632270 T2662212 T2748538 T2777556 T2791462 T2819791 T2851152 T2903828 K12T-07729A 00884450242230 T2281690 T2312131 T2326459 T2409291 T2431732 T2487376 T2540403 T2542192 T2550402 T2582678 T2597094 T2620393 T2642481 T2662214 T2718966 T2780115 T2806848 T2871321 T2878097 T2905960 T2915843 K12T-07845B 00884450292686 T2306074 T2310754 T2316766 T2316774 T2402613 T2457281 T2505823 T2508211 T2684484 T2699023 T2699024 T2752334 T2758651 T2762788 T2788896 T2805717 T2824485 T2845767 K12T-07893B 00884450482483 T2306183 T2366330 T2418046 T2488282 T2499649 T2662217 T2680671 T2736427 T2823666 T2905093 K12T-08003 00884450246252 T2329492 T2411629 T2587651 T2609918 T2635703 K12T-08565A 00884450279120 T2372630 T2457278 T2533244 T2545124 T2582688 T2599882 T2644161 T2704868 T2777576 T2814957 T2830382 T2859137 T2905158 K12T-08614B 00884450282397 T2584755 T2713015 K12T-08727B 00884450398661 T2246211 T2315034 T2387565 T2417454 T2447483 T2479833 T2543103 T2570370 T2587655 T2679690 T2736432 T2753178 T2806857 T2823672 T2903801 K12T-08801 00884450272688 T2571645 T2691099 K12T-08867 00884450274323 T2231298 K12T-09267D 00884450679319 T2431225 T2533310 T2572076 T2713227 T2840612 K12T-09337A 00884450360071 T2410201 T2418049 T2434526 T2479836 T2550428 T2605775 T2670972 T2704900 T2762037 T2815074 T2859816 T2907246 T2912515 K12T-09438A 00884450480861 T2869460 K12T-09523A 00884450383490 T2366339 T2407182 T2432256 T2509374 K12T-09595 00884450311189 T2164826 T2223529 T2269035 T2315043 T2332534 T2372678 T2418052 T2449520 T2463823 T2471517 T2547112 T2558267 T2587676 T2644263 T2693128 T2718982 T2780131 T2823677 T2866984 T2907301 T2915865 K12T-09685 00884450352380 T2409474 T2534386 T2609937 T2753182 T2764500 T2859160 K12T-09875 00884450329474 T2644271 T2701090 T2718986 T2787645 T2802422 T2820542 T2900345 K12T-09880A 00884450387870 T2759327 K12T-09889 00884450355923 T2232816 T2269103 T2315241 T2372683 T2418162 T2492449 T2583507 T2643817 T2721283 T2804974 T2859821 T2928271 K12T-09974A 00884450624913 T2753185 T2832405 T2879288 K12T-10167A 00884450795736 T2823501 T2870501 T2893596 K12T-10287 00884450398470 T2216993 T2431387 T2441503 T2534082 T2645393 T2777723 K12T-10338H 00884450632208 T2615306S K12T-10409 00884450399705 T2596990 T2705024 T2718845 T2753027 T2840454 K12T-10733 00884450419748 T2194562 T2316724 T2385145 T2417937 T2446644 T2490001 T2550121 T2570219 T2656616 T2693470 T2744141 T2779846 T2821665 T2849533 K12T-11467 00884450491720 T2366352 T2410205 T2418077 T2449532 T2485055 T2550581 T2583873 T2634286 T2662267 T2697043 T2697044 T2759104 T2816448 T2860507 T2900387 K12T-11524A 00884450601105 T2315069 T2358232 T2366354 T2434564 T2466026 T2471610 T2535678 T2560896 T2626306 T2662269 T2701132 T2719023 T2738034 T2780160 T2879799 T2908343 K12T-12152A 00884450733103 T2596903 K12T-12456 00884450794319 T2806980 T2903865 K22C-00001 00884450410844 T2538579 K22C-00001A 00884450443255 T2223542 T2232656 T2246239 T2299542 T2315077 T2329630 T2340035 T2367921 T2385416 T2407223 T2433228 T2448640 T2449543 T2479264 T2488290 T2538561 T2538568 T2560914 T2611912 T2644376 T2680768 T2713145 T2719248 T2738066 T2793877 T2825152 T2832448 T2876369 T2908907 K22C-00034 00884450412664 T2212048 T2443684 T2489925 T2571719 K22C-00035 00884450412695 T2403701 T2430290 T2565094 T2611005 T2753058 T2815881 T2841622 K22C-00042 00884450429853 T2283432 T2310762 T2316876 T2329631 T2366371 T2418087 T2434583 T2528424 T2545444 T2626480 T2644378 T2680770 T2774825 T2841627 T2887731 T2903795 T2929174 K22C-00043 00884450433133 T2248289 T2310580 T2387835 T2397230 K22C-00052 00884450445440 T2281678 T2283193 T2350825 T2385167 T2397088 T2434350 T2479676 T2548734 T2553489 T2605774 T2634626 T2643538 T2707335 T2753059 T2805919 T2832134 T2876224 K22C-00053A 00884450621028 T2681492 T2713155 T2778755 T2780182 K22C-00054A 00884450453445 T2780183 T2891592 K22C-00056 00884450438428 T2256529 T2329382 T2377583 T2407037 T2434353 T2466411 T2605754 T2643539 T2680494 K22C-00058A 00884450465271 T2258142 T2281679 T2355564 T2393191 T2407038 T2448642 T2489354 T2559696 T2583968 T2609638 T2697237 T2745091 T2832135 T2876227 K22C-00059 00884450457665 T2626491 T2657100 T2680771 T2697239 T2745092 T2762922 T2806990 T2861393 K22C-00062A 00884450522967 T2249249 T2385989 T2815884 T2917469 K22C-00064A 00884450568927 T2193750 T2208760 T2246002 T2299023 T2316880 T2349563 T2362889 T2377589 T2403710 T2433229 T2436921 T2437739 T2479266 T2498819 T2527133 T2531692 T2559698 T2656027 T2715230 T2736117 T2757433 T2778757 T2792385 T2792388 T2841457 T2865494 T2899731 T2939494 K22C-00069 00884450676301 T2431279 T2535806 T2609998 T2644380 T2662319 T2762221 K22C-00069A 00884450790755 T2832561 T2854496 K22C-00070 00884450678602 T2432171 T2535631 T2548740 T2570265 T2587399 T2625984 T2643540 T2701633 T2805920 T2823531 T2907226 T2926530 K22C-11010 00884450454480 T2231602 T2287828 T2312909 T2385168 T2424127 T2446806 T2470363 T2498879 T2643541

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 13 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fluid drainage tray), REF: PC101/B PC801 PC801/A PC802 PC802/A The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.

Z-2569-2024
Recall number
Z-2569-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
72115 kit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: PC101/B 00884450015278 T2158130 T2169450 T2199673 T2208910 T2223544 T2232658 T2241254 T2246241 T2248296 T2269052 T2278244 T2298721 T2299544 T2303828 T2303868 T2303870 T2312911 T2315079 T2329632 T2340038 T2351178 T2366374 T2382095 T2382096 T2398873 T2403711 T2431280 T2431281 T2434584 T2446766 T2464347 T2467230 T2477524 T2489926 T2513657 T2514888 T2518078 T2519083 T2550611 T2565097 T2566133 T2581123 T2587792 T2597130 T2610002 T2611975 T2611988 T2617249 T2632088 T2638072 T2652386 T2652389 T2652395 T2652396 T2657105 T2662320 T2680774 T2680775 T2687130 T2687131 T2713157 T2719249 T2738068 T2762224 T2781710 T2783882 T2786106 T2801582 T2802364 T2816169 T2818676 T2821641 T2823720 T2823722 T2829990 T2829992 T2838973 T2847768 T2850599 T2850884 T2854426 T2854427 T2867188 T2868244 T2876373 T2900566 T2900613 T2912473 T2912528 T2919513 T2932986 T2940181 PC201/B 00884450015285 T2185313 T2202175 T2208175 T2223545 T2269053 T2299545 T2315080 T2329634 T2362892 T2387856 T2433239 T2434585 T2449544 T2466092 T2479275 T2489930 T2514797 T2526980 T2531782 T2570307 T2587793 T2617255 T2635760 T2644381 T2657107 T2687133 T2713158 T2719251 T2788686 T2801587 T2814910 T2823723 T2850602 T2867189 T2876376 T2906834 T2906835 T2939054 PC801 00884450054017 T2208911 T2223546 T2246244 T2262305 T2269054 T2299546 T2306252 T2306254 T2329635 T2340039 T2366375 T2385421 T2424129 T2434586 T2449545 T2466183 T2489931 T2512280 T2517981 T2517985 T2550612 T2560916 T2568528 T2570989 PC801/A 00884450727911 T2611953 T2614842 T2614843 T2652398 T2662321 T2680776 T2683104 T2728045 T2728051 T2776680 T2782961 T2801591 T2801592 T2814922 T2823728 T2843866 T2852104 T2867190 T2882457 T2906079 PC802 00884450052297 T2208176 T2232659 T2292460 T2310770 T2329636 T2351179 T2382097 T2403714 T2424130 T2449551 T2479277 T2535830 T2560917 T2568529 T2570994 PC802/A 00884450727928 T2611934 T2614844 T2626504 T2652399 T2728053 T2786076 T2816480 T2847783 T2871500 T2885490 T2906078 T2932988 T2933746

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 14 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.

Z-2570-2024
Recall number
Z-2570-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
7442 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: RTT14038MB/A 00884450680100 T2882458 T2775532 T2692992 T2745797 T2823440 T2758669 T2882467 T2855297 T2692990 T2864420 T2762237 T2701080 T2748465 T2872143 T2853478 T2865442 T2560919 T2607047 T2617261 T2933737 T2657108 T2886240

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 15 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.

Z-2571-2024
Recall number
Z-2571-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
900 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: FCL-068-00/A 00884450484326 I2902415 I2828530 FCL-069-02/A 00884450484340 I2828531 I2838807 I2851067 I2853918 I2868010 FCL-069-03/A 00884450484357 I2853921

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 16 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.

Z-2572-2024
Recall number
Z-2572-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
30 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: PLP-2505/A 00884450510308 I2889564 PLP-2514/A 00884450510551 I2902220 PLP-2516/A 00884450510575 I2894297

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 17 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interventional procedures.

Z-2573-2024
Recall number
Z-2573-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
5700 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: OPT0242-00 00884450400586 T2167632 T2651487 T2327975 T2528428 T2845197 S1279-01 00884450050804 T2281682 T2409038 T2415675 T2449554 T2479912 T2599987 T2610007 T2681504 T2662328 T2713161 T2832455 T2890627 T2748983 T2780193 S2953 00884450050842 T2538578 T2625990 T2548814 T2574370 T2643543 T2702839 T2702565S T2736331 T2801599 T2924139 T2839019 T2890680 T2847794 S2960 00884450389058 T2542575 T2637160 T2872115 S6002 0088445005239 T2208823

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 18 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Z-2574-2024
Recall number
Z-2574-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
55305

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: PLS-1006/A 00884450467954 I2868407 I2873488 I2884101 I2889284 I2889285 I2889286 I2889287 I2889289 I2889288 I2903937 I2903938 I2903939 I2914399 I2925168 I2925169 PLS-1007/A 00884450467985 I2790541 I2862963 I2868410 I2868412 I2873489 I2882475 PLS-1008/A 00884450467992 I2868415 I2884088 I2889299 I2889300 I2661407S1 I2661408S1 I2925190 PLS-1009.5/A 00884450468036 I2862967 I2873494 I2889301 I2925173 PLS-1009/A 00884450468012 I2790564 I2873496 I2884103 I2889303 I2889306 PLS-1010.5/A 00884450468050 I2862970 PLS-1010/A 00884450468043 I2873497 I2873498 I2873499 I2873500 I2889327 PLS-1011/A 00884450468067 I2889329 PLS-2506/A 00884450468098 I2873501 I2889331 I2914419 PLS-2508/A 00884450468111 I2889334 PLS-2509/A 00884450468128 I2687649S1 I2868417 I2914426 PLS-2510/A 00884450468135 I2873503 I2889336 PLS-2511/A 00884450468159 I2889337 PLSX-1006/A 00884450489550 I2868420 I2873516 I2889355 I2914466 PLSX-1007/A 00884450489567 I2868421 I2873517 I2883775 I2903957 I2932677 PLSX-1008/A 00884450489574 I2889357 PLSX-1009/A 00884450489598 I2914468

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 19 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

Z-2575-2024
Recall number
Z-2575-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
745 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: PLSH-1006/A 00884450495049 I2868424 PLSH-1007/A 00884450495056 I2889342 I2903951 PLSH-1008/A 00884450495087 I2873505 PLSH-1009.5/A 00884450495568 I2873507 PLSH-2506/A 00884450495490 I2872319 I2914441 PLSH-2507/A 00884450495506 I2868427 I2889346

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 20 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.

Z-2576-2024
Recall number
Z-2576-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
317115 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: SPPT-100/D 00884450038659 T2382100 T2382102 T2748984 T2871502 T2666406 T2762926 T2824322 T2704382 T2863414 T2801600 T2382101 T2385423 T2407226 T2433246 T2717925 T2847798 T2433245 T2434587 T2438449 T2805260 T2587798 T2464348 T2479913 T2884261 T2498906 T2526998 T2530735 T2655953 T2931511 T2597132 T2565099 T2626508 T2657109 T2644387 SPPT-5F-10/D 00884450038673 T2351182 T2351183 T2367928 T2379511 T2379512 T2385424 T2398514 T2489934 T2498907 T2514802 T2753259 T2801601 T2730270 T2884264 T2879873 T2687139 T2779057 T2710244 T2861406 T2730271 T2823733 T2847801 T2704399 T2863441 T2662329 T2379513 T2424134 T2433247 T2464349 T2713162 T2805262 T2832456 T2805261 T2762927 T2433248 T2434588 T2438450 T2587799 T2472514 T2477549 T2900575 T2479284 T2622995S T2520450 T2520451 T2529637 T2626510 T2543014 T2583979 T2560921 T2610008 T2550617 T2655948 T2597133 T2587800 T2611991 T2657110 T2644390 SPPT-5F-10L/B 00884450038680 T2351188 T2365762 T2379520 T2388791 T2388793 T2680782 T2385425 T2713163 T2805263 T2779058 T2687141 T2863432 T2762928 T2823734 T2715257 T2867194 T2738091 T2852110 T2407228 T2422529 T2433254 T2489936 T2847803 T2779059 T2805264 T2433253 T2434589 T2448645 T2472525 T2479286 T2900576 T2900577 T2876381 T2885492 T2519031 T2519032 T2530734 T2626511 T2926546 T2550618 T2581125 T2587801 T2610010 T2916397 T2570319 T2657113 T2597134 T2612001 T2644391 T2655944 SPPT-5F-10S 00884450038697 T2351191 T2379524 T2385426 T2385427 T2581126 T2779063 T2871508 T2863417 T2762929 T2730272 T2814937 T2704392 T2407229 T2431282 T2503414 T2801602 T2847809 T2597135 T2626512 T2433255 T2448646 T2587802 T2472533 T2498909 T2655943 T2662331 T2464351 T2471637 T2943986 T2900578 T2543040 T2530736 T2612004 SPPT-5F-12PL 00884450277522 T2319777 T2368460 T2379527 T2438156 T2666491 SPPT-5F-17PL 00884450277546 T2385066 T2438155 T2662274 T2449563 SPPT-5F-7/D 00884450038703 T2351200 T2365767 T2384431 T2385430 T2762930 T2753262 T2704381 T2730273 T2379529 T2407234 T2422515 T2433256 T2503416 T2805292 T2847811 T2433257 T2466066 T2479289 T2498910 T2854442 T2639144 T2587803 T2626514 T2560922 T2660539 SPPT-5F-7L/B 00884450038710 T2762931 T2394395 T2353607 T2365772 T2379531 T2382113 T2680784 T2704397 T2730275 T2738092 T2900581 T2863440 T2823736 T2852163 T2713165 T2753263 T2403749 T2418097 T2433258 T2498911 T2805293 T2587804 T2801603 T2867195 T2433259 T2434591 T2448647 T2472573 T2479291 T2900580 T2503555 T2884271 T2530737 T2657117 T2581127 T2933550 T2543006 T2581129 T2612007 T2610013 T2639145 T2670040 SPPT-5F-7S 00884450038727 T2560924 T2385699 T2398572 T2753264 T2704387 T2738093 T2610014 T2407235 T2433262 T2867196 T2780197 T2847812 T2438461 T2636646 T2655958 T2466022 T2479293 T2527002 T2587805 T2912446 SPPT-6F-10L 00884450277560 T2928291 SPPT-6F-10S 00884450277577 T2719257 T2655851 SPPT-6F-12PL 00884450277584 T2389562 T2666121 T2431283 T2704402 SPPT-6F-12PS 00884450277591 T2704428 SPPT-6F-17PL 00884450277607 T2438157 SPPT-8F-10L 00884450277645 T2340050 T2365801 T2670041 T2610015 T2530907 T2587806 T2379536 T2407236 T2469351 T2495435 T2527005 T2527006 T2704427 T2779065 T2719258 T2805324 T2847814 SPPT-8F-12PL 00884450277669 T2867197 T2766169 T2823737 T2710256 T2802562 T2871509 T2859151 TAPS-100 00884450038734 T2379537 T2385432 T2780199 T2704383 T2738095 T2730276 T2823738 T2863411 T2394396 T2394396S T2407237 T2418101 T2498913 T2805327 T2433263 T2464352 T2472587 T2527008 T2657216 T2586465 T2626516 T2884273 T2543029 T2587807 T2639146 TAPS-5F-10LT 00884450038741 T2489939 T2523240 T2523242 T2526967 T2550619 T2560925 T2543030 T2574187 T2581130 T2587808 T2587809 T2674794 T2597136 T2597137 T2639157 T2662335 T2730277 T2626517 T2704391 T2753266 T2779066 T2644396 T2762932 T2871512 T2900587 T2719266 T2832457 T2823739 T2687146 T2738096 T2655951 T2713167 T2805329 T2814938 T2801748 T2657218 T2847817 T2869841 T2855428 T2876383 T2939875 T2885495 T2943546 T2925561 T2916403 TAPS-5F-10T 00884450038758 T2477572 T2489945 T2489946 T2526968 T2527009 T2542370 T2526969 T2543031 T2550620 T2584574 T2597138S T2587810 T2588953 T2597138 T2610016 T2687149 T2814940 T2900588 T2762933 T2644401 T2869850 T2655950 T2707349 T2730278 T2753268 T2657227 T2869838 T2823740 T2779068 T2847823 T2805330 T2879882 T2861413 T2925562 TAPS-5F-12PLT 00884450277737 T2489947 T2498944 T2644403 T2601813 T2655936 T2610017 T2570347 T2527010 T2805332 T2710243 T2710255 T2814941 T2818677 T2832459 T2854447 T2867200 T2920424 TAPS-5F-17PLT 00884450277751 T2570343 T2539964 T2644405 T2587811 T2697253 TAPS-5F-7LT 00884450038765 T2503569 T2543034 T2586466 T2597140 T2612085S T2655960 T2626521 T2884282 T2859181 T2707365 T2762934 T2719267 T2832460 T2801751 T2921077 T2916407 TAPS-5F-7T 00884450038772 T2503571 T2530988 T2560927 T2581131 T2597141S T2597141 T2713168 T2687153 T2638243 T2762935 T2814942 T2753269 T2655961 T2916408 T2854448 TAPS-6F-10LT 00884450277775 T2543035 T2587812 T2612086 T2623038 T2655826 T2823742 T2674854 T2779070 T2655827 T2713170 T2839074 T2738097 T2801757 T2859148 T2861424 T2919527 TAPS-6F-10T 00884450277782 T2527013 T2624657 T2591150 T2626525 T2657254 T2704429 T2852200 T2814943 T2779071 T2710242 T2933774 TAPS-6F-12PLT 00884450277799 T2489956 T2498939 T2525411 T2560928 T2626526 T2662337 T2612087 T2525410 T2730279 T2655937 T2707415 T2680790 T2814944 T2805335 T2876384 T2855447 TAPS-6F-12PT 00884450277805 T2501701 T2639080 T2612088 T2666120 T2900593 T2662338 T2853505 T2738098 T2713171 T2846633 T2801761 T2939879 TAPS-6F-17PLT 00884450277812 T2704430 TAPS-6F-7T 00884450277843 T2511831 T2584573 T2587813 TAPS-8F-10LT 00884450277850 T2666569 T2662340 T2832461 T2707366 T2928290 T2910071 TAPS-8F-10T 00884450277867 T2543036 T2494488 T2662341 T2666122 T2687162 T2704386 T2867202 T2809724 T2900595 TAPS-8F-12PLT 00884450277874 T2556800 T2533088 T2623003 T2687163 T2655949 T2626531 T2910072 T2753272 T2704388 T2713173 TAPS-8F-12PT 00884450277881 T2713174 TAPS-8F-17PLT 00884450277898 T2527049 T2570344 T2597142 T2636647 T2587816 T2697258 T2713176 T2861427 T2666123 T2916412 TAPS-8F-17PT 00884450277904 T2753274 T2710258 T2739243

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 21 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.

Z-2577-2024
Recall number
Z-2577-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
4027 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: FCL-083-02/A 00884450484418 I2808956 I2851068 I2868011 I2931690 WOR-CSG-B1-09/A 00884450484319 I2786685 I2808954 I2818469 I2818470 I2818471 I2828532 I2828533 I2838811 I2851070 I2853922 I2853923 I2868006 I2868008 I2879275 I2889546 I2889548 I2893943 I2901154 I2902413 I2902414 I2912319 I2941927 WOR-CSG-B2-09/A 00884450484456 I2786687 I2818472 I2828534 I2838814 I2853925 I2868009 I2879276 I2889549 I2901183 WOR-CSG-BL1-09/A 00884450484463 I2902412 I2912321 WOR-CSG-E-90/A 00884450484487 I2803269 I2851069 I2931689

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 22 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J K09T-09843AP K09T-10192B K09T-10405A K09T-10449 K09T-10542G K09T-10790D K09T-10899C K09T-11052F K09T-11266B K09T-11305F K09T-11372G K09T-11496A K09T-11541B K09T-11831C K09T-11940A K09T-11940B K09T-12050D K09T-12292B K09T-12558D K09T-12624B K09T-13050F K09T-13097B K09T-13097C K09T-13232 K09T-13257 K09T-13335B K09T-13362A K09T-13362B K09T-13468A K09T-13469A K09T-13521C K09T-13595A K09T-13666 K09T-13801 K09T-14072A K09T-14106 K10T-03350C K10T-04039F K10T-04245G K10T-04385G K10T-04448M K10T-04486D K10T-04486F K10T-04741 K10T-04845G K10T-05008B K10T-05199B K10T-05342D K10T-05468F K10T-05581B K10T-05602A K10T-05745B K10T-05991A K10T-06073 K12T-01749D K12T-02061A K12T-02061B K12T-02162B K12T-02460F K12T-03044G K12T-03327G K12T-03723C K12T-03975B K12T-04229H K12T-04312T K12T-04323G K12T-04324D K12T-04849C K12T-04997F K12T-05302H K12T-05302J K12T-05396D K12T-05519C K12T-05524F K12T-05674D K12T-05741 K12T-05741A K12T-06472 K12T-06693C K12T-06823D K12T-06823F K12T-06899 K12T-07098 K12T-07204A K12T-07351C K12T-07543F K12T-07543G K12T-07545B K12T-07703A K12T-07822F K12T-07918C K12T-08368B K12T-08769B K12T-08980 K12T-09026A K12T-09129H K12T-09195A K12T-09350 K12T-09354 K12T-09526B K12T-09586 K12T-09722 K12T-09890A K12T-09922C K12T-10006 K12T-10006A K12T-10006B K12T-10006C K12T-10024 K12T-10092A K12T-10121A K12T-10235A K12T-10262A K12T-10293D K12T-10311 K12T-10316A K12T-10489B K12T-10489C K12T-10584A K12T-10653 K12T-10660D K12T-10778C K12T-10978A K12T-10996B K12T-11004A K12T-11069 K12T-11091 K12T-11098B K12T-11116B K12T-11124 K12T-11229A K12T-11326A K12T-11405B K12T-11471B K12T-11514A K12T-11615A K12T-11626A K12T-11672 K12T-11759 K12T-12078 K12T-12078B K12T-12200A K12T-12275 K12T-12276 K12T-12278 K12T-12405 K12T-12466 K12T-12499 K17T-00008 K17T-00010B K17T-00013 To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures

Z-2578-2024
Recall number
Z-2578-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
168157 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: K09T-01138 00884450336007 T2363424 T2386670 T2408156 T2480761 T2550174 T2571631 T2635757 T2640323 T2734947 T2774657 T2805967 T2833068 T2843260 T2850761 T2873975 T2885243 T2906058 K09T-04484A 00884450566596 T2816450 T2832465 T2854450 T2871539 T2901668 K09T-04757F 00884450388396 T2385183 T2434454 T2495466 T2525635 T2556829 T2584607 T2597014 T2640329 T2675582 T2708063 T2805969 T2843261 T2885245 T2895071 T2916416 K09T-04835H 00884450270394 T2287853 T2315252 T2349573 T2360340 T2386004 T2390911 T2414694 T2434737 T2449763 T2494448 T2587504 T2635754 T2667679 T2680871 T2712317 T2738104 T2781020 T2807074 T2833069 T2846966 T2864503 T2876387 K09T-07256D 00884450603703 T2360341 T2442955 T2498994 T2512482 T2560718 T2662053 T2745275 T2753062 T2800989 T2816846 K09T-07588B 00884450264386 T2205472 T2241180 T2314951 T2329404 T2349817 T2385184 T2386005 T2399751 T2442956 T2466089 T2479716 T2515708 T2536603 T2556831 T2560719 T2587556 T2606272 T2623834 T2657321 T2662059 T2690340 T2718870 T2748986 T2779872 T2800990 T2816851 T2846968 T2864504 T2874066 T2881132 T2906059 K09T-07611K 00884450290392 T2596860 T2652491 T2699218 T2699221 T2708069 T2717940 T2738107 T2762257 T2800991 T2833071 T2849220 T2883795 T2886087 T2939092 K09T-07649K 00884450390627 T2305612 K09T-07649L 00884450644102 T2339957 T2366225 T2386671 T2407056 T2417965 T2456584 T2495473 T2525638 T2550175 T2571768 T2594494 T2606278 T2640321 T2676814 K09T-07649M 00884450763506 T2712330 T2800995 T2805971 T2829278 T2846972 T2895076 T2913241 T2918196 K09T-09035H 00884450390634 T2305169 K09T-09035J 00884450644119 T2407057 T2417968 T2449348 T2456585 T2495474 T2525665 T2550176 T2587558 T2614918 T2640322 T2662061 T2676826 T2739363 K09T-09035M 00884450783108 T2774709 T2801082 K09T-09035N 00884450801956 T2832138 T2845195 T2850766 T2883742 T2886099 T2936006 K09T-09107K 00884450388402 T2333502 T2428903 T2457858 T2495482 T2551032 T2584608 T2643751 T2807078 K09T-09319C 00884450336328 T2333503 T2406792 T2426303 T2442997 T2479557 T2495485 T2525667 T2542381 T2570205 T2667684 T2676839 T2697309 T2726942 T2750320 T2779735 T2800998 T2805468 T2824416 T2899053 K09T-09599Q 00884450305485 T2657331 K09T-09672H 00884450400142 T2262333 T2322586 T2349973 T2370013 T2382254 T2390913 T2418132 T2428904 T2454371 T2471274 T2499030 T2525672 T2536622 T2550679 T2587433 T2606292 T2636536 T2676303 T2680820 T2708087 T2738112 T2786079 T2801005 T2823766 T2831465 K09T-09672J 00884450806500 T2843279 T2885516 T2898660 K09T-09843AP 00884450396100 T2634757 K09T-10192B 00884450273326 T2606293 T2647494 T2657421 T2667760 K09T-10405A 00884450388426 T2435072 T2449671 T2495513 K09T-10449 00884450229255 T2269725 T2298788 T2320198 T2354640 T2484242 T2501039 T2571619 T2581479 T2627904 T2679655 T2712890 T2734943 T2781721 T2805975 T2810457 T2824612 T2918261 K09T-10542G 00884450386798 T2327703 T2385009 T2572026 T2596862 T2682149 T2699228 T2764349 T2789920 T2792298 T2864577 T2876388 K09T-10790D 00884450603710 T2397998 T2407058 T2446365 T2466116 T2491596 T2538587 T2571762 T2597021 T2619221 T2633111 T2676861 T2700131 T2736359 T2779938 T2805976 T2847942 T2866729 T2895720 T2901758 K09T-10899C 00884450261262 T2256693 T2327704 T2366465 T2397999 T2418184 T2495532 T2499083 T2528610 T2572079 T2643754 T2699197 T2712368 T2792307 T2847943 T2854453 T2876389 T2895202 K09T-11052F 00884450624302 T2366390 T2443045 T2443049 T2473866 T2499065 T2531651 T2566151 T2599040 T2627386 T2650516 T2697340 T2721146 T2761341 T2781022 T2807093 T2840610 T2847945 T2864582 T2916421 K09T-11266B 00884450400883 T2435084 T2499032 T2550685 T2554945 T2584613 T2614985 T2635783 T2667765 T2700133 T2712373 T2833078 T2899814 K09T-11305F 00884450297971 T2307586 T2333520 T2366391 T2389983 T2428911 T2432410 T2474025 T2480890 T2525700 T2525703 T2550687 T2576051 T2587438 T2636553 T2657501 T2676882 T2699967 T2712374 T2748993 T2781023 T2804759 T2833079 T2847946 T2876391 T2906107 K09T-11372G 00884450372333 T2480900 T2506600 T2536629 T2581320 T2606314 T2699169 T2766980 K09T-11496A 00884450658307 T2367270 T2404513 T2436016 T2436056 T2446736 T2474270 T2474271 T2489362 T2525719 T2566155 T2587562 T2597022 T2621657 T2643840 T2643841 T2643955 T2700134 T2736361 T2792309 T2802363 T2821673 T2828941 T2861637 T2877008 T2877011 T2901790 K09T-11541B 00884450501573 T2299771 T2333521 T2360397 T2399791 T2443059 T2525726 T2540032 T2561863 T2587440 T2615034 T2652525 T2667774 T2701716 T2733148 T2734952 T2762263 T2792311 T2816438 T2823773 T2842472 T2847957 T2898995 K09T-11831C 00884450538012 T2233977 T2301004 T2308773 T2330885 T2370016 T2406793 T2489184 T2520012 T2520012S T2543072 T2570254 T2596739 T2602899 T2625816 T2657587 T2697337 T2736190 T2762721 T2800812 T2816483 T2826108 T2871660 T2898969 K09T-11940A 00884450271834 T2299469 T2466260 T2525740 K09T-11940B 00884450747520 T2759124 K09T-12050D 00884450410738 T2417972 T2428927 T2457873 T2511582 T2525742 T2561872 T2597024 T2636564 T2667776 T2700138 T2708155 T2823536 T2824589 T2874176 T2899094 T2919405 K09T-12292B 00884450408735 T2275682 T2310877 T2313747 T2366231 T2370019 T2414779 T2436532 T2489372 T2495552 T2531647 T2550182 K09T-12558D 00884450570104 T2246166 T2313748 T2322850 T2349146 T2386022 T2426491 T2449353 T2498991 T2550183 T2606419 T2643958 T2667818 T2700141 T2701718 T2746562 T2781174 T2816452 T2843378 T2850770 T2903861 T2910068 K09T-12624B 00884450571132 T2652571 K09T-13050F 00884450592670 T2241181 T2291335 T2322853 T2363573 T2382390 T2417973 T2449354 T2495602 T2520402 T2521610 T2542504 T2626068 T2652592 T2658303 T2677439 T2697327 T2753074 T2765368 T2804977 T2810460 T2823538 T2850784 T2918319 K09T-13097B 00884450525609 T2550693 T2556889 T2587442 T2647601 T2676926 T2766472 T2807102 K09T-13097C 00884450801703 T2823540 T2898993 K09T-13232 00884450451045 T2350042 T2562888 T2636578 T2651327 T2716023 T2832578 T2873226 K09T-13257 00884450454473 T2329408 T2520362 T2536815 T2560723 T2708162 T2805981 K09T-13335B 00884450630303 T2407065 T2466058 T2489378 T2542577 T2550188 T2636580 T2658306 T2676938 T2734258 T2781182 K09T-13362A 00884450486771 T2262339 T2360420 K09T-13362B 00884450640128 T2314788 T2427532 T2823395 T2842267 T2899102 K09T-13468A 00884450522103 T2496484 T2708954 K09T-13469A 00884450533109 T2327706 T2366393 T2428991 T2457893 T2525939S T2543084 T2615167 T2652604 T2700145 T2712381 T2738118 K09T-13521C 00884450586136 T2329410 T2350942 T2377796 T2417974 T2449356 T2489116 T2490328 T2516490 T2587567 T2615174 T2640337 T2697317 T2774796 T2779943 K09T-13595A 00884450561102 T2340067 T2370022 T2386033 T2408837 T2435085 T2466009 T2489117 T2489117S T2536863 T2543992 T2578864 T2615176 T2636583 T2676942 T2697368 K09T-13666 00884450557709 T2241182 T2278117 T2313751 T2366237 T2414797 T2457895 T2536866 T2566217 T2587568 T2636584 T2662071 T2750438 T2775000 T2792414 T2805989 T2843389 T2895215 T2898695 K09T-13801 00884450709702 T2540582 T2587569 T2636585 T2662072 T2805991 T2823545 K09T-14072A 00884450790939 T2842479 T2887235 T2926868 T2929478 K09T-14106 00884450746523 T2658313 T2661297 T2832148 T2848026 T2871959 T2890781 T2898982 K10T-03350C 00884450388471 T2622665 T2643310 T2894194 K10T-04039F 00884450267400 T2248493 T2299854 T2315255 T2333576 T2360519 T2426596 T2792473 T2840603 K10T-04245G 00884450455524 T2146383 T2217680 T2268993 T2295584 T2306525 T2313755 T2329417 T2350955 T2360555 T2399851 T2399854 T2439257 T2474213 T2516018 T2536363 T2577080 T2587578 T2622510 T2643979 T2697310 T2753078 T2779953 T2779955 T2800720 T2810484 T2823555 T2866742 T2901990 T2918296 T2927177 K10T-04385G 00884450390948 T2636624 K10T-04448M 00884450400852 T2266445 T2288418 T2306124 T2343674 T2345489 T2366239 T2398005 T2408839 T2417980 T2446368 T2466069 T2489383 T2498963 T2519306 T2536918 T2550217 T2560735 T2584662 T2609812 T2636627 T2658519 T2677556 T2701754 T2712897 T2727040 T2740097 T2779961 T2788932 T2806016 T2853502 T2876254 T2898985 K10T-04486D 00884450442883 T2278118 T2313767 T2350957 T2360564 T2404587 T2417981 T2457351 T2527538 T2531643 T2560736 T2597031 T2635769 T2764415 T2775478 T2832152 K10T-04486F 00884450794302 T2823558 T2866743 T2885313 T2899887 T2918401 K10T-04741 00884450319369 T2539998 K10T-04845G 00884450454077 T2278319 T2306367 T2345515 T2345517 T2360581 T2383168 T2407270 T2429111 T2435089 T2443498 T2456517 T2473871 T2499039 T2527572 T2587451 T2616582 T2627411 T2699253 T2699260 T2712419 T2738141 T2833109 T2842489 T2912464 K10T-05008B 00884450363768 T2429156 T2449363 T2485374 T2498957 T2527606 T2550223 T2626086 T2666112 T2701790 T2736368 T2789665 T2802870 T2832164 T2848436 K10T-05199B 00884450455531 T2232543 T2246170 T2295614 T2313783 T2407071 T2443504 T2458451 T2489389 T2550227 T2597033 T2626088 T2662082 T2697360 T2718890 T2792502 T2833112 T2850806 K10T-05342D 00884450495780 T2314965 T2339966 T2385206 T2479740 T2560739 T2581442 T2697331 T2775546 T2806065 T2862544 T2899890 K10T-05468F 00884450584538 T2644045 T2657334 K10T-05581B 00884450542514 T2290391 T2370534 T2412581 T2527729 T2597036 T2773368 T2816402 T2902680 K10T-05602A 00884450388525 T2269088 T2329670 T2351646 T2397211 T2443577 T2497067 T2499026 T2531668 T2577222 T2596872 T2621517 T2670922 T2709043 T2738155 T2754777 T2764066 T2840631 T2873227 T2902684 K10T-05745B 00884450499573 T2256889 T2314969 T2414962 T2458538 T2479747 T2550248 T2561908 T2597039 T2644049 T2677677 T2779989 T2802944 T2833139 T2848598 T2899106 K10T-05991A 00884450619902 T2266481 T2339972 T2407078 T2498125 T2581497 T2637215 T2709056 T2801100 T2830833 T2874295 T2918492 K10T-06073 00884450676912 T2437006 T2443508 T2776688 T2840772 T2928284 K12T-01749D 00884450337493 T2849225 T2899060 T2902780 K12T-02061A 00884450337844 T2269001 T2329441 T2415928 T2437737 T2498655 K12T-02061B 00884450721278 T2555169 T2560750 T2591136 T2644059 T2677759 T2773352 T2817159 T2875230 K12T-02162B 00884450048986 T2570270 T2587425 T2627315 T2677760 T2697328 T2780033 T2823616 T2900191 K12T-02460F 00884450388969 T2128177 T2169198 T2225628 T2278126 T2314974 T2346091 T2385231 T2407081 T2443689 T2479750 T2503572 T2524654 T2585638 T2609838 T2677838 T2712907 T2727084 T2816334 T2850848 T2895679 T2921250 K12T-03044G 00884450585115 T2214901 T2241194 T2283366 T2306142 T2339983 T2371560 T2406221 T2417997 T2458768 T2489446 T2489453 T2519014 T2519015 T2543129 T2571761 T2597050 T2626193 T2653289 T2677861 T2729008 T2762872 T2790677 T2816287 T2850895 T2895853 T2900197 K12T-03327G 00884450238950 T2241325 T2283495 T2315230 T2334447 T2357823 T2371561 T2408267 T2418148 T2437821 T2471150 T2492439 T2529661 T2545188 T2581674 T2596882 T2627437 T2659933 T2680841 T2697353 T2712496 T2747367 T2781049 T2821704 T2842520 T2879932 T2906837 T2918628 K12T-03723C 00884450389423 T2241201 T2385277 T2418000 T2503584 T2529728 T2555766 T2597056 T2710696 T2794209 T2823628 K12T-03975B 00884450767726 T2728059 T2850920 T2898975 K12T-04229H 00884450312995 T2262327 T2300691 T2324292 T2329375 T2361334 T2401035 T2414125 T2421993 T2465921 T2499022 T2530822 T2557758 T2563095 T2585688 T2627319 T2697326 T2728111 T2736391 T2781177 T2785562 T2823634 T2844819 T2876297 T2919441 K12T-04312T 00884450685907 T2627440 T2650605 T2719607 K12T-04323G 00884450532720 T2582267 T2631380 T2635531 T2703944 K12T-04324D 00884450411049 T2668820 T2680633 T2680633S T2710752 T2734946S K12T-04849C 00884450372326 T2361517 T2407115 T2422260 T2483723 T2526991 T2545400 T2560762 T2585785 T2619388 T2644083 T2679024 T2704223 T2722033 T2764682 T2776306 T2816476 T2850991 T2872257 T2898879 K12T-04997F 00884450343487 T2531050 T2550336 T2587611 T2710787 T2747755 T2806230 T2852296 K12T-05302H 00884450631706 T2349212 T2385973 T2401814 T2434492 T2449470 K12T-05302J 00884450696903 T2531089 T2550343 T2571776 T2607544 T2626219 T2660520 T2704298 T2762884 T2811801 T2830694 T2897090 T2907032 K12T-05396D 00884450463451 T2545964 T2555950 T2609863 T2662187 T2736404 T2776862 T2820401 T2851061 T2872265 T2893604 T2899136 T2900212 K12T-05519C 00884450333785 T2221441 T2245319 T2280356 T2314837 T2350755 T2366180 T2387241 T2406930 T2434257 T2465835 T2479641 T2531820 T2532770 T2557849 T2587301 T2611001 T2643375 T2671716 T2728171 T2735061 T2776869 T2803923 T2828847 T2858599 T2888281 T2904701 K12T-05524F 00884450457047 T2385294 T2407123 T2437378 T2568629 T2587622 T2609867 T2638081 T2680649 T2806250 T2848047 T2858600 T2869389 T2887604 T2900216 K12T-05674D 00884450363751 T2241212 T2262165 T2304150 T2329473 T2355810 T2390521 T2407128 T2438705 T2479809 T2514687 T2538681 T2560778 T2597816 T2609872 T2660531 T2666532 T2700040 T2712955 T2729192 T2762260 T2795240 T2834918 T2851099 T2897658 K12T-05741 00884450345849 T2232254 T2291426 T2314768 T2324623 T2392979 T2401918 T2431467 T2459207 T2475933 T2493327 T2545986 T2557861 T2587229 T2609512 T2679117 K12T-05741A 00884450771907 T2728212 T2734139 T2779705 T2803957 T2842249 T2869392 T2904738 K12T-06472 00884450202050 T2211054 K12T-06693C 00884450647707 T2347923 T2366311 T2396510 T2434513 T2486134 T2550385 T2552387 T2640148 T2681637 T2714799 T2897697 T2904946 K12T-06823D 00884450388563 T2476675 T2557919 T2597084 K12T-06823F 00884450782729 T2823473 K12T-06899 00884450350294 T2406947 T2470265 K12T-07098 00884450351024 T2246262 T2329662 T2354413 T2396535 T2407258 T2445822 T2532458 T2550663 T2570278 T2610033 T2640179 T2672064 T2716743 T2785645 T2819577 T2851149 T2903820 K12T-07204A 00884450231210 T2661392 K12T-07351C 00884450553503 T2487247 T2560817 T2644150 T2662210 T2766556 T2806368 K12T-07543F 00884450553312 T2406952 T2441212 T2487282 T2489302 T2546307 K12T-07543G 00884450720301 T2563998 T2587332 T2680428 T2712096 T2758638 T2788685 T2805460 T2823481 T2853349 T2876104 T2909813 K12T-07545B 00884450529935 T2532511 T2550399 T2597092 T2672074 T2773362 T2806843 T2900334 K12T-07703A 00884450243640 T2329488 K12T-07822F 00884450553305 T2262052 T2291831 T2314862 T2380410 T2402612 T2440067 T2466365 T2489304 T2533080 T2547006 T2568782 T2609593 T2679640 T2712136 T2748549 T2748578 T2819853 T2845766 T2882865 T2907084 K12T-07918C 00884450537909 T2155695 T2191463 T2213834 T2272065 T2305934 T2372626 T2431738 T2461098 T2526985 T2550085 T2570253 T2596968 T2620403 T2679645 T2748561 T2791465 T2805719 T2853351 T2899788 T2937822 K12T-08368B 00884450493427 T2241232 T2278199 T2298121 T2312142 T2349717 T2407167 T2434523 T2449514 T2498982 T2532459 T2543188 T2582687 T2626246 T2644159 T2691064 T2713013 T2748564 T2780121 T2802687 T2821674 K12T-08769B 00884450559956 T2245994 T2309952 T2327759 T2359018 T2406776 T2431758 T2446564 T2478309 T2509746 T2547057 T2569464 T2621445 T2655334 T2672231 T2712024 T2729911 T2779715 T2830389 T2865486 T2915858 K12T-08980 00884450278741 T2267678 T2286724 T2315037 T2409457 T2440198 T2533283 T2533284 T2587661 T2655351 T2718975 T2777614 T2845188 T2907187 K12T-09026A 00884450297261 T2222628 T2291888 K12T-09129H 00884450545317 T2668523 T2712200 T2777619 T2821703 T2832585 T2854503 K12T-09195A 00884450390054 T2609599 T2679721 K12T-09350 00884450295182 T2240648 T2269033 T2315040 T2329513 T2351145 T2466010 T2479851 T2505579 T2531486 T2571661 T2632552 K12T-09354 00884450293577 T2232616 T2305149 T2332530 T2385326 T2417457 T2440292 T2479853 T2490361 T2587670 T2644254 T2693119 T2704905 T2814334 T2838490 T2888491 K12T-09526B 00884450684535 T2583975 T2655379 T2712184 K12T-09586 00884450352359 T2146570 T2169415 T2208875 T2223528 T2232620 T2299530 T2366341 T2410168 T2534380 T2545453 T2592918 K12T-09722 00884450313350 T2572022 T2632572 T2632574 T2839735 T2867234 K12T-09890A 00884450395172 T2326712 T2409485 T2587364 T2699034 T2805791 K12T-09922C 00884450482513 T2534407 T2547461 T2558296 T2600452 T2632617 T2670728 T2684838 T2704965 T2717600 T2781137 T2839750 T2867340 K12T-10006 00884450360392 T2167777 T2199596 T2241148 T2262082 T2306089 T2350815 T2385136 K12T-10006A 00884450679302 T2432433 T2435888 T2449299 T2479661 K12T-10006B 00884450707852 T2554117 T2560620 T2587366 T2592904 T2618791 T2655387 T2656083 T2712154 T2753024 T2762797 T2805801 T2822648 T2832084 K12T-10006C 00884450816912 T2879927 K12T-10024 00884450363553 T2406998 T2540001 T2583516 T2680454 T2753025 K12T-10092A 00884450391594 T2262215 K12T-10121A 00884450538913 T2232627 T2310432 T2407195 T2445158 T2493086 T2558308 T2587693 T2609945 T2705014 T2738020 T2762902 T2849221 K12T-10235A 00884450456545 T2656563 T2748611 K12T-10262A 00884450396520 T2417934 T2470501 T2550112 T2596987 T2621542 T2643476 T2804755 T2822654 T2846062 T2908146 K12T-10293D 00884450760932 T2680696 T2684862 T2718995 K12T-10311 00884450396643 T2680455 K12T-10316A 00884450401514 T2244075 T2278211 T2315056 T2337658 T2359158 T2407200 T2432587 T2466091 T2571712 T2597112 T2644291 T2662241 T2680698 T2748581 T2762903 T2806896 T2846064 T2882931 K12T-10489B 00884450452639 T2146596 T2223531 T2268922 T2316717 T2329580 T2409795 T2423543 T2466205 T2498974 T2547553 T2547555 T2583645 T2621768 T2627676 T2644294 T2700067 T2728044 T2777732 K12T-10489C 00884450789575 T2791619 T2822672 T2851177 T2903864 T2915883 K12T-10584A 00884450499566 T2232635 T2511850 T2587740 T2802464 T2823682 K12T-10653 00884450412930 T2402686 T2459220 T2478888 K12T-10660D 00884450723302 T2564844 T2635758 T2693468 T2738179 T2791622 T2840524 T2908170 K12T-10778C 00884450544914 T2656626 T2777746 T2840538 T2913313 K12T-10978A 00884450552315 T2337714 T2373023 T2441909 T2534833 T2550769 T2564889 T2587480 T2651562 T2670730 T2713234 T2804973 T2815689 T2815693 T2879296 T2909825 K12T-10996B 00884450515105 T2222777 T2278061 T2299442 T2328152 T2387781 T2464757 T2493704 T2550126 T2559476 T2643502 T2679832 T2801084 T2822730 T2889514 T2889814 K12T-11004A 00884450456897 T2327017 T2355552 T2435101 T2499040 T2543065 T2572040 T2633489 T2679833 T2816419 T2903846 K12T-11069 00884450455470 T2498975 T2533106 T2587746 T2605762 T2637163 T2644306 T2701128 T2719009 T2762907 T2780146 T2806911 T2815207 T2846104 T2876342 T2909854 T2919496 K12T-11091 00884450457856 T2222806 K12T-11098B 00884450630105 T2338232 T2373026 T2543041 T2635706 K12T-11116B 00884450638156 T2627288 T2738180 T2903120 K12T-11124 00884450464625 T2679841 K12T-11229A 00884450519707 T2232642 T2306216 T2385376 T2418072 T2448006 T2550573 T2644312 T2708157 T2719012 T2823688 T2879929 K12T-11326A 00884450504727 T2591151 T2741685 K12T-11405B 00884450638163 T2627281 T2725797 T2903116 K12T-11471B 00884450571309 T2223538 T2232645 T2262228 T2312849 T2385400 T2433139 T2466288 T2489768 T2535676 T2550582 T2583875 T2609961 T2662268 T2717699 K12T-11514A 00884450519912 T2355557 T2373050 T2407213 T2433140 T2471512 T2499652 T2699557 T2791634 T2831872 T2867124 K12T-11615A 00884450538029 T2340083 T2424000 T2433150 T2485415 T2535681 T2550770 T2587482 T2680858 T2713235 T2814339 T2818300 T2919690 K12T-11626A 00884450541715 T2283428 K12T-11672 00884450526958 T2253559 T2305714 T2409900 T2489350 T2535687 T2656112 T2805863 T2879926 K12T-11759 00884450543979 T2146613 T2214923 T2231512 T2315073 K12T-12078 00884450719329 T2555757 T2571779 K12T-12078B 00884450792704 T2792961 T2854368 T2901427 K12T-12200A 00884450813102 T2866325 T2908477 K12T-12275 00884450732908 T2642488 T2642490 T2908483 K12T-12276 00884450732915 T2642489 T2642491 K12T-12278 00884450719336 T2559634 T2559646 K12T-12405 00884450745502 T2643533 T2697231 T2854854 T2907227 K12T-12466 00884450804308 T2829997 K12T-12499 00884450832103 T2923985 K17T-00008 00884450241578 T2202168 T2262094 K17T-00010B 00884450411056 T2146342 T2208819 T2222502 T2246081 T2283190 T2314892 T2394331 T2433210 T2466373 T2534072 T2545145 T2570214 T2601707 T2634617 T2663683 T2680491 T2712189 T2762829 T2805909 T2815794 T2854858 T2865721 T2916389 K17T-00013 00884450287354 T2434346 T2466353 T2509998 T2550141 T2574377 T2643534 T2712190 T2778752 T2815876 T2853466 T2909851

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

device · product 23 of 23

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K05-02166B K05T-00380C K05T-01674B K05T-01863 K05T-01941C K05T-01955 K05T-02138 K05T-02159 K05T-02272G K05T-02272H K05T-02515A K05T-02533 K05T-02728 K05T-02733C K05T-03153 K05T-03201 K09T-00318D K09T-07304G K09T-07627L K09T-07627M K09T-08747 K09T-08774F K09T-08952 K09T-09037J K09T-09358 K09T-09576J K09T-09760C K09T-09978A K09T-10485L K09T-10728H K09T-10728J K09T-11022C K09T-11022D K09T-11379F K09T-11430B K09T-11478A K09T-11738D K09T-11798 K09T-11875B K09T-12020B K09T-12020C K09T-12200 K09T-12538F K09T-12538G K09T-12883B K09T-12883C K09T-12942B K09T-12942C K09T-12942D K09T-12942F K09T-12970B K09T-13293 K09T-13293A K09T-13294 K09T-13294A K09T-13384B K09T-13384C K09T-13444B K09T-13459A K09T-13459B K09T-13681A K09T-13740 K09T-13927 K09T-13927A K09T-13949 K09T-13972 K09T-14025 K09T-14028B K09T-14035 K09T-14072 K09T-14218 K10T-01528G K10T-01528H K10T-03769F K10T-04233J K10T-04941B K10T-05595A K10T-05611B K10T-05680B K10T-06085 K10T-06085A K10T-06101 K10T-12092 K10T-12092A K12-05727F K12T-01737D K12T-01816A K12T-01996K K12T-02064 K12T-02285F K12T-02667A K12T-02703C K12T-02703F K12T-02911F K12T-02911G K12T-02940 K12T-03196 K12T-03312 K12T-03724F K12T-03933C K12T-03975A K12T-03979C K12T-04085 K12T-04270A K12T-04271B K12T-04348A K12T-04383G K12T-04707 K12T-04926G K12T-05302D K12T-05303D K12T-05303F K12T-05327D K12T-05432F K12T-05432G K12T-05627 K12T-05849C K12T-05849D K12T-05849F K12T-05850B K12T-05850C K12T-05903B K12T-05968D K12T-05974A K12T-05996M K12T-05996N K12T-06043 K12T-06313B K12T-06412A K12T-06431A K12T-06436 K12T-06694A K12T-06821 K12T-06826 K12T-06839A K12T-07986C K12T-08071C K12T-08071D K12T-08072D K12T-08072F K12T-08166D K12T-08703 K12T-08964F K12T-09013F K12T-09237A K12T-09292A K12T-09338D K12T-09456B K12T-09840B K12T-10464 K12T-10514A K12T-10515 K12T-10515A K12T-10516 K12T-10562 K12T-10583A K12T-10586A K12T-10649 K12T-10664A K12T-10881B K12T-11049 K12T-11151 K12T-11586 K12T-11626B K12T-11626C K12T-11680 K12T-11684 K12T-11826 K12T-11853P K12T-11857B K12T-11880 K12T-11880A K12T-11880B K12T-11901 K12T-11903 K12T-11910 K12T-11923 K12T-11923A K12T-11924A K12T-11925A K12T-11943B K12T-11943C K12T-11984 K12T-11985 K12T-11996 K12T-12017 K12T-12091 K12T-12138 K12T-12149 K12T-12153 K12T-12155 K12T-12155A K12T-12155B K12T-12157 K12T-12157A K12T-12157B K12T-12224 K12T-12224A K12T-12224B K12T-12230 K12T-12242 K12T-12242A K12T-12244 K12T-12285A K12T-12291 K12T-12291A K12T-12323 K12T-12331A K12T-12397 K12T-12403 K12T-12406 K12T-12406A K12T-12407 K12T-12419 K12T-12448 K12T-12448A K12T-12494 K12T-11210 K12T-12321 K20T-00002 K20T-00004A K20T-00012 K20T-00016A K20T-00019 K20T-00027 K20T-00031 K20T-00035 K12T-02045 K12T-02909 K12T-03993A K12T-06280 K12T-09329A K12T-09368A K12T-10157 K12T-12095 K05T-01920F K09T-10485M K09T-14028 K09T-14028A K10-04922C K10T-00554J K10T-00554L K10T-00861D K10T-01428A K10T-01785L K10T-02735D K10T-03122A K10T-03348K K10T-03627F K10T-03627G K10T-03627H K10T-03776F K10T-03776G K10T-03784 K10T-03810A K10T-03810B K10T-03979M K10T-04060G K10T-04113Q K10T-04113R K10T-04160R K10T-04163H K10T-04199C K10T-04200C K10T-04256H K10T-04338G K10T-04415K K10T-04463D K10T-04500B K10T-04578B K10T-04655B K10T-04718F K10T-04723B K10T-04744D K10T-04774D K10T-04775 K10T-04780 K10T-04806A K10T-04844N K10T-04861B K10T-04862 K10T-04892 K10T-04983B K10T-04986F K10T-05012G K10T-05012H K10T-05081F K10T-05082G K10T-05165A K10T-05197B K10T-05219 K10T-05272C K10T-05307B K10T-05308B K10T-05365A K10T-05366B K10T-05367 K10T-05397 K10T-05451N K10T-05451R K10T-05462 K10T-05493B K10T-05504C K10T-05518 K10T-05531 K10T-05541C K10T-05541D K10T-05592B K10T-05593C K10T-05612 K10T-05651B K10T-05655 K10T-05662 K10T-05665A K10T-05666 K10T-05666A K10T-05667F K10T-05667G K10T-05667H K10T-05670B K10T-05711A K10T-05711B K10T-05746A K10T-05747A K10T-05797 K10T-05812A K10T-05817 K10T-05819

Z-2579-2024
Recall number
Z-2579-2024
Initiated
June 11, 2024
Classification
Class II
Status
Ongoing
Quantity
1,753,625 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code information

Catalog Number/UDI-DI code/Lot Numbers: TKITS-CI K05-02166B 00884450499597 T2199559 T2241078 T2282965 T2314787 T2449229 T2350723 T2408151 T2865497 T2490391 T2434206 T2495447 T2549930 T2587249 T2542280 T2718618 T2643306 T2687167 T2762714 T2779728 T2805456 T2823368 T2853484 K05T-00380C 00884450286999 T2428876 T2445382 T2465777 T2505820 T2614851 T2479555 T2560483 T2587250 T2636525 T2697344 T2730359 T2916415 T2745227 T2779731 T2792255 T2805457 T2842259 T2865498 K05T-01674B 00884450140796 T2390906 T2425906 T2453860 T2823388 T2800974 T2774647 T2853488 T2899143 K05T-01863 00884450315347 T2317007 T2397063S T2366145 T2425907 T2470012 T2587251 T2505851 T2533799 T2525473 T2623832 T2625813 T2718633 T2762715 T2805459 T2823390 T2863782 T2910718 K05T-01941C 00884450235386 T2363422 T2390908 T2428877 T2466078 T2495453 T2548913 T2597012 T2584604 T2687170 T2652469 T2627880 T2712308 T2779868 T2753061 T2899028 T2866724 T2816242 K05T-01955 00884450140826 T2345281 T2399661 T2464322 T2470005 T2386001 T2587403 T2765333 T2643557 T2719601 T2823391 T2861459 K05T-02138 00884450140833 T2313700 T2349568 T2363423 T2386669 T2621412 T2479311 T2533804 T2549003 T2745251 T2726918 T2716870 K05T-02159 00884450140840 T2397995 T2561788 T2417859 T2434208 T2509792 T2801089 T2762716 T2549931 T2625814 T2675576 T2893877 K05T-02272G 00884450684023 T2708057 T2448644 T2479556 T2549932 T2525579 T2536595 T2643308 T2587252 T2596738 T2675577 T2726919 T2774653 T2759596 T2810448 T2843256 T2800975 K05T-02272H 00884450814710 T2871522 T2898650 K05T-02515A 00884450255797 T2246086 T2295357 T2317021 T2355732 T2708058 T2434420 T2436222 T2464320 T2479677 T2498901 T2550150 T2584606 T2602771 T2596837 T2774655 T2643558 T2800976 T2667623 T2682131 T2849520 T2842263 T2823393 T2895062 T2898651 K05T-02533 00884450255803 T2470008 T2390909 T2417860 T2509879 T2525626 T2698958 T2620280 T2876922 T2718634 T2849216 T2809725 T2909932 T2899055 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02728 00884450235768 T2232330 T2300859 T2310997 T2333495 T2310972 T2360346 T2386002 T2697318 T2436240 T2457782 T2495460 T2505739 T2536598 T2549933 T2587253 T2647453 T2643309 T2667633 T2834062 T2762718 T2736188 T2864486 T2901664 T2918188 K05T-02733C 00884450410813 T2223646 T2495463 T2315211 T2342954 T2322340 T2333496 T2536600 T2397194 T2407260 T2418130 T2428881 T2449669 T2697342 T2587431 T2623833 T2627379 T2676794 T2738103 T2708061 T2773344 T2818284 T2823759 T2876928 T2898652 T2931544 K05T-03153 00884450463796 T2407053 T2408155 T2442952 T2479713 T2542359 T2788780 T2587555 T2675580 T2748985 T2850760 T2816275 K05T-03201 00884450547915 T2327701 T2349571 T2625815 T2390910 T2470017 T2489182 T2533261 T2762719 T2549934 T2718635 T2690357 T2656028 T2823394 K09T-00318D 00884450388389 T2300861 T2329688 T2349572 T2370009 T2386003 T2403812 T2442953 T2495464 T2550789 T2521167 T2521168 T2680870 K09T-07304G 00884450671948 T2400947 T2407054 T2479715 T2447477 T2525636 T2541147 T2635779 T2676810 T2662054 T2708067 T2781718 T2833070 T2861463 K09T-07627L 00884450336151 T2428888 T2436257 T2457838 T2495467 T2550678 T2627380 T2572024 T2517476 T2652496 T2738109 T2676813 T2643765 T2699225 T2800993 T2587432 K09T-07627M 00884450794616 T2807076 T2816853 T2871586 T2933811 T2832466 K09T-08747 00884450411582 T2448462 T2299466 T2322585 T2417966 T2329405 T2360363 T2646157 T2382188 T2386672 T2403854 T2864506 T2434457 T2471545 T2849271 T2781172 T2697320 T2909806 T2560720 T2538556 T2585644 T2657322 T2587557 T2781183 T2748988 T2712889 T2779900 T2811085 K09T-08774F 00884450242957 T2700125 T2700174 T2721142 T2408157 T2745276 T2843278 T2779902 T2864507 T2465907 T2537746 T2550622 T2599043 T2643845 T2599045 T2676822 K09T-08952 00884450048139 T2636529 K09T-09037J 00884450268575 T2647476 T2805972 T2709965 T2832139 T2680800 T2758211 T2718873 T2779930 T2800997 T2827650 T2850767 T2899091 K09T-09358 00884450048160 T2643752 T2596904 T2676841 T2774730 T2807079 T2712336 T2687178 T2635782 T2813397 T2842463 K09T-09576J 00884450264942 T2708078 T2614920 K09T-09760C 00884450356883 T2550681 T2495503 T2340130 T2408160 T2457860 T2495502 T2906066 T2825544S T2861306 T2551388 T2576362 T2596861 T2594515 T2652504 T2890713 T2773341 T2699226 T2801006 T2816386 K09T-09978A 00884450387733 T2389864 K09T-10485L 00884450479346 T2333962 K09T-10728H 00884450486290 T2299757 T2349143 T2350033 T2370015 T2414731 T2428909 T2399783 T2676859 T2707467 T2773363 T2636546 T2449672 T2479986 T2723021 T2792303 T2525684 T2550683 T2551442 T2587437 T2823769 K09T-10728J 00884450821503 T2905920 T2918279 K09T-11022C 00884450388440 T2366226 T2386674 T2465609 T2414736 T2452710 T2428910 T2636552 T2499632 T2525696 T2525697 T2587561 T2626063 T2646163 T2576000 K09T-11022D 00884450777909 T2811153 T2779939 T2860467 T2740344 T2853503 T2805977 T2861336 K09T-11379F 00884450290682 T2314761 T2322587 T2403966 K09T-11430B 00884450332191 T2223657 T2278316 T2315213 T2360396 T2499025 T2390915 T2407263 T2435079 T2512481 T2525707 T2550690 T2699229 T2587439 T2643767 T2699230 T2854455 T2738115 T2781185 T2801013 T2823772 T2898973 K09T-11478A 00884450229446 T2494453 T2435073 T2492160 T2531649 T2556857 T2615000 T2627391 T2647509 T2776358 T2697332 T2801015 T2849284 T2864585 T2918282 K09T-11738D 00884450571903 T2281935 T2310866 T2317059 T2350037 T2386675 T2407062 T2428915 T2457870 T2479724 T2536659 T2581322 T2550181 T2652527 T2595210 T2633414 T2786071 T2660481 T2700135 T2823535 T2753073 T2676897 T2697313 T2876235 T2832142 T2910720 K09T-11798 00884450391945 T2366468 T2428921 T2860052 T2449764 T2495544 K09T-11875B 00884450337035 T2241306 T2241388 T2266306 T2266307 T2382380 T2397197 T2418135 T2492162 T2662259 T2847961 K09T-12020B 00884450337066 T2307603 T2318412 T2329692 T2626458 T2399794 T2643738 T2432648 T2436497 T2477357 T2516137 T2566156 T2587515 T2733788 T2738191 T2657597 T2700136 T2818675 T2801027 K09T-12020C 00884450782736 T2807336 T2867311 T2847962 T2832566 T2901793 T2929258 T2906122 K09T-12200 00884450263358 T2525743 T2457874 T2550691 T2732947 T2655945 T2712378 T2906137 T2847967 T2816358 T2773334 K09T-12538F 00884450600740 T2536714 T2549936 T2511923 T2536391 K09T-12538G 00884450720318 T2566182 T2609539 T2697329 T2712044 T2729330 T2800944 T2773324 T2881143 T2864592 K09T-12883B 00884450436820 T2219765 T2256703 T2278116 K09T-12883C 00884450651711 T2428965 T2536728 T2354376 T2366234 T2414784 T2511926 T2554949 T2576129 T2550184 T2587564 T2680893 T2628709 T2639079 T2754397 T2732930 T2718880 K09T-12942B 00884450471272 T2301020 T2322851 T2360406 T2386676 T2449386 T2443102 T2412118 T2445157 K09T-12942C 00884450689882 T2523903S T2474174 T2499074 T2523903 T2561851 T2536738 K09T-12942D 00884450728970 T2627394 T2650341 T2671527 T2602591 T2624736 T2712298 T2666398 K09T-12942F 00884450772546 T2786082 T2738543 T2752216 T2854497 T2819034 T2818684 T2881525 T2901795 T2933805 T2917957 K09T-12970B 00884450483053 T2885536 T2832571 T2824590 T2842451 K09T-13293 00884450641712 T2339960 T2428968 T2407063 K09T-13293A 00884450692509 T2480958 T2499008 T2543189 T2647604 T2587565 T2850787 T2792313 T2550187 T2489376 T2626069 T2697370 T2774990 T2816299 T2895211 T2823542 T2901851 K09T-13294 00884450641729 T2339961 T2407064 T2428970 K09T-13294A 00884450692516 T2677626 T2480980 T2779942 T2871662 T2499009 T2609786 T2587566 T2525907 T2697315 T2716659 T2862020 T2816300 T2792314 T2899881 T2885272 K09T-13384B 00884450584347 T2330900 T2407264 K09T-13384C 00884450682913 T2448827 T2466023 T2866379 T2838004 T2805987 T2542579 T2549028 T2866382 T2903881 T2597025 T2571771 T2697319 T2636581 T2727012 T2776359 K09T-13444B 00884450533123 T2295562 T2278359 T2313749 T2490835 T2474196 T2587516 T2615152 T2635755 T2531644 T2636582 T2670722 T2699170 T2774993 T2708953 T2813399 T2823750 T2901852 K09T-13459A 00884450708729 T2584633 T2614036 K09T-13459B 00884450744505 T2639152 T2847979 T2667824 T2734956 T2774995 T2667827 T2814327 T2816436 T2895212 T2931539 K09T-13681A 00884450611104 T2609540 T2584647 K09T-13740 00884450574379 T2283315 T2314960 T2355736 T2412155 T2436992 T2550190 T2667842 T2773369 T2571753 T2609787 T2736362 T2816439 T2781737 T2876244 K09T-13927 00884450655900 T2383210 T2408150 T2443107 T2485273 T2499003 T2525945 T2587570S T2550192 T2635751 T2637288 T2606434 K09T-13927A 00884450744512 T2662073 T2712893 T2779944 T2761301 T2801881 T2823546 T2843390 T2850789 T2876248 T2898696 K09T-13949 00884450663905 T2399821 T2536870 K09T-13972 00884450668733 T2407640 T2898697 T2479727 T2676948 T2417975 T2587571 T2606435 T2712894 T2823547 T2753075 T2850790 T2801092 T2876249 T2918340 K09T-14025 00884450698105 T2511835 T2587572 T2550193 T2525947 T2658311 T2849272 T2700146 T2716662 T2901855 T2746575 T2762838 T2876251 K09T-14028B 00884450751114 T2676953 T2849291 T2762839 K09T-14035 00884450720387 T2609789 T2554963 T2672345 T2576304 T2736363 T2587573 T2805994 K09T-14072 00884450731918 T2612331 T2600363 T2823776 T2754609S T2612334 T2772994 T2743265S T2738119 T2766979 T2809848 T2717534 T2788918 K09T-14218 00884450816417 T2901856 K10T-01528G 00884450335185 T2166214 T2351640 T2299513 T2327707 T2435080 T2397200 T2496548 T2492450 T2687351 T2643775 T2536891 T2587444 T2738121 T2781030 T2823782 K10T-01528H 00884450815113 T2917988 T2872011 K10T-03769F 00884450290675 T2199997 T2232531 T2268992 T2295581 T2299470 T2360504 K10T-04233J 00884450585924 T2205564 T2802010 T2306123 T2323017 T2385199 T2407069 T2425253 T2437115 T2466312 T2496626 T2666114 T2528380 T2599064 T2595390 T2697345 T2775451 T2899096 T2816441 T2862474 K10T-04941B 00884450232866 T2643991 T2690349 T2712900 T2814360 T2779966 T2909809 T2832154 K10T-05595A 00884450337301 T2550734 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00884450522189 T2816426 K12T-08964F 00884450522189 T2924244 K12T-08964F 00884450522189 T2854488 K12T-08964F 00884450522189 T2888456 K12T-09013F 00884450760710 T2713021 K12T-09013F 00884450760710 T2838117 K12T-09013F 00884450760710 T2816392 K12T-09013F 00884450760710 T2718976 K12T-09013F 00884450760710 T2785670 K12T-09013F 00884450760710 T2871372 K12T-09013F 00884450760710 T2907192 K12T-09237A 00884450309704 T2155800 K12T-09237A 00884450309704 T2164033 K12T-09237A 00884450309704 T2194648 K12T-09237A 00884450309704 T2211652 K12T-09237A 00884450309704 T2231305 K12T-09237A 00884450309704 T2244035 K12T-09237A 00884450309704 T2281570 K12T-09237A 00884450309704 T2299529 K12T-09237A 00884450309704 T2543922 K12T-09237A 00884450309704 T2326547 K12T-09237A 00884450309704 T2350781 K12T-09237A 00884450309704 T2402635 K12T-09237A 00884450309704 T2366335 K12T-09237A 00884450309704 T2407176 K12T-09237A 00884450309704 T2425074 K12T-09237A 00884450309704 T2429980 K12T-09237A 00884450309704 T2444088 K12T-09237A 00884450309704 T2449517 K12T-09237A 00884450309704 T2488428 K12T-09237A 00884450309704 T2498950 K12T-09237A 00884450309704 T2780128 K12T-09237A 00884450309704 T2570355 K12T-09237A 00884450309704 T2597102 K12T-09237A 00884450309704 T2638246 K12T-09292A 00884450563700 T2245996 K12T-09292A 00884450563700 T2287535 K12T-09292A 00884450563700 T2312153 K12T-09292A 00884450563700 T2305947 K12T-09292A 00884450563700 T2327763 K12T-09292A 00884450563700 T2348253 K12T-09292A 00884450563700 T2364199 K12T-09292A 00884450563700 T2385043 K12T-09292A 00884450563700 T2476656 K12T-09292A 00884450563700 T2406783 K12T-09292A 00884450563700 T2434202 K12T-09292A 00884450563700 T2480524 K12T-09338D 00884450479858 T2627497 K12T-09338D 00884450479858 T2643744 K12T-09338D 00884450479858 T2854504 K12T-09338D 00884450479858 T2511387 K12T-09338D 00884450479858 T2760446 K12T-09338D 00884450479858 T2801506 K12T-09338D 00884450479858 T2844109 K12T-09338D 00884450479858 T2822486 K12T-09456B 00884450311714 T2223527 K12T-09456B 00884450311714 T2351155 K12T-09456B 00884450311714 T2366338 K12T-09456B 00884450311714 T2385329 K12T-09456B 00884450311714 T2587674 K12T-09456B 00884450311714 T2560883 K12T-09456B 00884450311714 T2571685 K12T-09456B 00884450311714 T2661557 K12T-09840B 00884450673706 T2915868 K12T-09840B 00884450673706 T2822504 K12T-09840B 00884450673706 T2786885 K12T-09840B 00884450673706 T2894213 K12T-09840B 00884450673706 T2524597 K12T-09840B 00884450673706 T2592867 K12T-10464 00884450400913 T2232819 K12T-10464 00884450400913 T2262487 K12T-10464 00884450400913 T2540252 K12T-10464 00884450400913 T2315244 K12T-10464 00884450400913 T2605771 K12T-10464 00884450400913 T2550768 K12T-10464 00884450400913 T2680854 K12T-10464 00884450400913 T2707855 K12T-10464 00884450400913 T2713232 K12T-10464 00884450400913 T2764150 K12T-10464 00884450400913 T2824127 K12T-10514A 00884450489338 T2246228 K12T-10514A 00884450489338 T2305614 K12T-10514A 00884450489338 T2283398 K12T-10514A 00884450489338 T2315059 K12T-10514A 00884450489338 T2348789 K12T-10514A 00884450489338 T2385349 K12T-10514A 00884450489338 T2447890 K12T-10514A 00884450489338 T2407202 K12T-10514A 00884450489338 T2432593 K12T-10514A 00884450489338 T2466063 K12T-10514A 00884450489338 T2478884 K12T-10514A 00884450489338 T2523632 K12T-10514A 00884450489338 T2508374 K12T-10514A 00884450489338 T2609949 K12T-10514A 00884450489338 T2550494 K12T-10514A 00884450489338 T2587739 K12T-10514A 00884450489338 T2644297 K12T-10514A 00884450489338 T2679805 K12T-10514A 00884450489338 T2713093 K12T-10514A 00884450489338 T2717612 K12T-10514A 00884450489338 T2777733 K12T-10514A 00884450489338 T2822675 K12T-10514A 00884450489338 T2822676 K12T-10514A 00884450489338 T2846066 K12T-10514A 00884450489338 T2907981 K12T-10514A 00884450489338 T2867002 K12T-10514A 00884450489338 T2876340 K12T-10514A 00884450489338 T2915885 K12T-10515 00884450456835 T2348636 K12T-10515 00884450456835 T2397226 K12T-10515 00884450456835 T2407448 K12T-10515 00884450456835 T2432594 K12T-10515 00884450456835 T2435099 K12T-10515 00884450456835 T2449714 K12T-10515 00884450456835 T2471200 K12T-10515 00884450456835 T2534741 K12T-10515 00884450456835 T2553283 K12T-10515A 00884450740620 T2627451 K12T-10515A 00884450740620 T2624754 K12T-10515A 00884450740620 T2620298 K12T-10515A 00884450740620 T2723038 K12T-10515A 00884450740620 T2801421 K12T-10515A 00884450740620 T2824125 K12T-10515A 00884450740620 T2816435 K12T-10515A 00884450740620 T2840627 K12T-10515A 00884450740620 T2867239 K12T-10515A 00884450740620 T2882954 K12T-10516 00884450457986 T2627498 K12T-10516 00884450457986 T2693248 K12T-10516 00884450457986 T2587521 K12T-10516 00884450457986 T2710900 K12T-10516 00884450457986 T2610053 K12T-10516 00884450457986 T2801423 K12T-10516 00884450457986 T2499089 K12T-10516 00884450457986 T2511380 K12T-10516 00884450457986 T2822681 K12T-10516 00884450457986 T2869613 K12T-10516 00884450457986 T2897758 K12T-10562 00884450408933 T2232821 K12T-10562 00884450408933 T2278328 K12T-10562 00884450408933 T2326787 K12T-10562 00884450408933 T2348637 K12T-10562 00884450408933 T2387771 K12T-10562 00884450408933 T2397028 K12T-10562 00884450408933 T2432597 K12T-10562 00884450408933 T2447892 K12T-10562 00884450408933 T2587479 K12T-10562 00884450408933 T2493338 K12T-10562 00884450408933 T2572030 K12T-10562 00884450408933 T2633288 K12T-10562 00884450408933 T2545151 K12T-10562 00884450408933 T2534761 K12T-10562 00884450408933 T2673423 K12T-10562 00884450408933 T2699321 K12T-10562 00884450408933 T2777734 K12T-10583A 00884450589656 T2479876 K12T-10583A 00884450589656 T2305617 K12T

Distribution pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.