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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66837

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

Open FDA event record

Event summary

Timeline bucket
November 22, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD, 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

13 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 13

4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1180-2014
Recall number
Z-1180-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2485103 2493959 2498064 2511207 2521581 2525780 2525781 2533316 2547272 2574207 2578556 2472508 2476319 2467728 2497730

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 2 of 13

4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1181-2014
Recall number
Z-1181-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2463876 2472511 2476324 2476325 2480609 2485108 2489875 2493965 2503422 2503423 2506814 2511211 2513709 2521588 2529536 2533320 2536817 2547283 2551262 2551263 2560919 2560920 2569052 2569053 2574217 2463876

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 3 of 13

4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1182-2014
Recall number
Z-1182-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2459798 2472512 2472513 2476329 2480613 2480614 2489880 2493968 2498070 2503427 2506816 2511212 2513711 2521591 2521592 2525786 2529541 2533323 2547290 2547291 2551266 2555870 2560932 2569056 2569057 2569058 2463882 2467732 2574219

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 4 of 13

4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1183-2014
Recall number
Z-1183-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2489881 2503429 2513713 2525788 2555872 2472514

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 5 of 13

4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1184-2014
Recall number
Z-1184-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2485116 2489882 2498071 2503431 2506818 2511214 2521593 2533326 2542764 2547293 2555873 2560933 2569066 2578565 2459802 2472515

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 6 of 13

4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1185-2014
Recall number
Z-1185-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2459795 2476328 2503425 2521590 2529540 2533322 2551265 2560930 2569055 2574218

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 7 of 13

4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1186-2014
Recall number
Z-1186-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2476326 2480611 2493966 2493967 2506812 2506813 2529537 2529539 2533321 2536818 2536820 2547286 2459794 2463880 2463881

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 8 of 13

4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1187-2014
Recall number
Z-1187-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2476330 2476331 2485112 2485113 2485115 2493970 2493971 2493972 2506817 2511213 2525787 2529542 2536822 2538273 2542763 2459801 2467733 2467734

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 9 of 13

G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1188-2014
Recall number
Z-1188-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2467804 2480661 2503528 2503529 2521653 2529597 2529598 2551329 2572218 2572220 2467805

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 10 of 13

G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1189-2014
Recall number
Z-1189-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2530465 2530465

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 11 of 13

G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1190-2014
Recall number
Z-1190-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2483968 2492596 2496746 2500736 2505477 2514016 2524048 2529356 2536681 2541173 2554034 2475168

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 12 of 13

G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1191-2014
Recall number
Z-1191-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2491431

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.

device · product 13 of 13

G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.

Z-1192-2014
Recall number
Z-1192-2014
Initiated
November 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Code information

2548332

Distribution pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.