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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94239

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

Open FDA event record

Event summary

Timeline bucket
March 14, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

9 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 9

Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Heart Catheterization Pack, Pack #DYNJ30927Q, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. d. Medline Heart Catheterization Pack, Pack #DYNJ30927R, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. e. Medline Minor Special Procedure Pack, Pack #DYNJ38326G, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. f. Medline Perm Cath Tray, Pack #DYNJ40423A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. g. Medline CRMC Angiogram-LF, Pack #DYNJ61082F, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. h. Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099D, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. i. Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099F, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. j. Medline Cath Lab Pack, Pack #DYNJ81995, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. k. Medline Cardiac Cath, Pack #DYNJ82907, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. l. Medline Special Procedure Tray, Pack #DYNJ83626, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Cath Lab Pack, Pack #DYNJ83924, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. n. Medline Cath Lab Pack, Pack #DYNJ83924A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. o. Medline Cath Pack, Pack #DYNJ84739, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. p. Medline Cardiac Cath Pack, Pack #DYNJ85872, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. q. Medline Pacemaker Pack, Pack #DYNJ55340C, containing a Pure Pouch with component Sterile Straight Kelly Hemostat, Reorder #66170. r. Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118G, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. s. Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118I, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. t. Medline Endovascular Pack, Pack #DYNJ66727B, containing a Pure Pouch with component Sterile 6" SnagFree Mayo Needle Holder, Reorder #66430. u. Medline Endovascular Pack, Pack #DYNJ66727C, containing a Pure Pouch with component Sterile 6" SnagFree Mayo Needle Holder, Reorder #66430. v. Medline IR Central Kit, Pack #DYNJ68285A, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175. w. Medline Biopsy Tray MVH, Pack #DYNJ63560B, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175. x. Medline FFX Drainage Tray, Pack #DYNJ82142, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.

Z-2224-2024
Recall number
Z-2224-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
12,588 total sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

a. Pack #00-RDF0360 - lot numbers 24AMF652, exp. 11/30/2026, 23IMD552, exp. 6/30/2026, and 23DMI750, exp. 7/31/2025, UDI-DI each-10195327195618, UDI-DI case-40195327195619. b. Pack #DYNJ26488W - lot number 23EDA461, exp. 10/31/2025, UDI-DI each-10195327209780, UDI-DI case-40195327209781. c. Pack #DYNJ30927Q - lot numbers 23IMB725, exp. 4/30/2026, and 23GMI473, exp. 1/31/2026, UDI-DI each-10195327164225, UDI-DI case-40195327164226. d. Pack #DYNJ30927R - lot numbers 23LMH572, exp. 5/31/2026, 23KMH917, exp. 6/30/2026, 23KMD083, exp. 5/31/2026, and 23KMB895,exp. 10/31/2025, UDI-DI each-10195327539160, UDI-DI case-40195327539161. e. Pack #DYNJ38326G - lot numbers 23KMB384, exp. 5/3/2025, and 23HME988, exp. 5/31/2025, UDI-DI each 10195327230135, UDI-DI case-40195327230136. f. Pack #DYNJ4423A - lot number 23JBC229, exp. 8/31/2027, UDI-DI each-10889942346998, UDI-DI case-40889942346999. g. Pack #DYNJ61082F - lot numbers 23HMG768, exp. 3/31/2026, UDI-DI each-10195327451783, UDI-DI case-40195327451784. h. Pack #DYNJ61099D - lot numbers 23JBN632, exp. 1/31/2026, UDI-DI each-10195327451790, UDI-DI case-40195327451791. i. Pack #DYNJ61099F - lot numbers 24ABB295, exp. 4/30/2026, UDI-DI each-10195327561925, UDI-DI case-40195327561926. j. Pack #DYNJ81995 - lot numbers 23JMA624, exp. 8/31/2026, and 23GME739, exp. 4/30/2026, UDI-DI each-10195327163471, UDI-DI case 40195327163472. k. Pack #DYNJ82097 - lot number 23GME848, exp. 7/31/2025, UDI-DI each-10195327169701, UDI-DI case-40195327169702. l. Pack #DYNJ83626 - lot numbers 24AMG191, exp. 11/30/2026, 23HME813, exp. 2/28/2026, and 23EMI882, exp. 2/28/2026, UDI-DI each-10195327286873, UDI-DI case 40195327286874. m. Pack #DYNJ83924 - lot numbers 23FBH281, exp. 7/31/2027, UDI-DI each-10195327314835, UDI-DI case-40195327314836. n. Pack #DYNJ83924A - lot numbers 23KBQ984, exp. 1/31/2028, and 23KBN818, exp. 1/31/2028, UDI-DI each-10195327507206, UDI-DI case-40195327507207. o. Pack DYNJ84739 - lot numbers 23KMG773, exp. 8/31/2026, and 23JMB674, exp. 2/28/2025, UDI-DI each-10195327409272, UDI-DI case-40195327409273. p. Pack DYNJ85872 - lot number 24BBB337, exp. 9/30/2026, UDI-DI each-10195327562724, UDI-DI case-40195327562725. q. Pack DYNJ55340C - lot number 23FMC559, exp. 9/30/2025, UDI-DI each-10195327352912, UDI-DI case 40195327352913. r. Pack #DYNJ61118G - lot numbers 23JME718, exp. 5/31/2025, and 23GME956, exp. 5/31/2026, UDI-DI each-10195327451745, UDI-DI case-40195327451746. s. Pack #DYNJ61118I - lot number 23KMG830, exp. 5/31/2025, UDI-DI each-10195327561918, UDI-DI case 40195327561919. t. Pack #DYNJ66727B - lot numbers 23GBT746, exp. 4/30/2024, 23FBM310, exp. 5/31/2024, and 23EBJ690, exp. 2/29/2024, UDI-DI each-10195327299088, UDI-DI case-40195327299089. u. Pack #DYNJ66727C - lot number 23JBV616, exp. 6/30/2024, UDI-DI each-10195327511135, UDI-DI case-40195327511136. v. Pack #DYNJ68285A - lot number 23DMH178, exp. 7/31/2025, UDI-DI each-10193489878653, UDI-DI case-40193489878654. w. Pack #DYNJ63560B - lot numbers 23LLA770, exp. 3/31/2025, 23JLA771, exp. 1/31/2025, and 23ILA367, exp. 1/31/2025, UDI-DI each-10193489417500, UDI-DI case-40193489417501. x. Pack #DYNJ82142 - lot numbers 23HLB135, exp. 2/28/2026, and 23GLA498, exp. 4/30/2025, UDI-DI each-10195327177874, UDI-DI case-40195327177875. y. Pack #DYNJ47873L - lot numbers 23KBW512, exp. 8/31/2027, UDI-DI each-10195327506896, UDI-DI case-40195327506897. z. Pack #DYNJ56073C - lot numbers 23IDA509, exp. 5/31/2026, and 23DDC159, exp. 11/30/2025, UDI-DI each-10193489441833, UDI-DI case-40193489441834.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 2 of 9

Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.

Z-2225-2024
Recall number
Z-2225-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
12,588 total sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

Pack #DYNJ47873L - lot numbers 23KBW512, exp. 8/31/2027, UDI-DI each-10195327506896, UDI-DI case-40195327506897.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 3 of 9

Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.

Z-2226-2024
Recall number
Z-2226-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
12,588 total sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

Pack #DYNJ56073C - lot numbers 23IDA509, exp. 5/31/2026, and 23DDC159, exp. 11/30/2025, UDI-DI each-10193489441833, UDI-DI case-40193489441834.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 4 of 9

Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.

Z-2227-2024
Recall number
Z-2227-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
12,588 total sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

Pack #DYNJ38429D containing component 65945 - lot numbers 23JMF534, exp. 12/31/2024, 23JMC032, exp. 5/31/2024, 23HMD025, exp. 5/31/2024, and 23GMC207, exp. 5/31/2024. Pack #DYNJ38429D containing component 67645 - lot number 23HMH776, exp. 5/31/2024.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 5 of 9

Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile. c. Medline Sterile Loop Insertion Tray, Pack DYNJ62843A, containing a Pure Pouch containing Medline Reorder #DYNJ04048, Kelly Forceps/Std Str Sterile. d. Medline Radiology Minor MVH, Pack #DYNJ63555C, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. e. Medline Basic Pack, Pack #DYNJ80649B, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.

Z-2228-2024
Recall number
Z-2228-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
12,588 total sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

a. Pack #DYNJ47873K - lot numbers 23HBK868, exp. 8/31/2027, 23HBC082exp. 2/29/2028, 23GBC462, exp. 1/31/2028, and 23DBK792, exp. 11/30/2027, UDI-DI each 10193489466812 and UDI-DI case-40193489466813. b. Pack #DYNJ56141A - lot numbers 23IBK595, exp. 1/31/2025, UDI-DI each-10193489555585 and UDI-DI case-40193489555586. c. Pack DYNJ62843A - lot numbers 24ABP043, exp. 12/31/2024, and 23IBM893, exp. 3/31/2025, UDI-DI each-10195327001766 and UDI-DI case-40195327001224. d. Pack #DYNJ63555C - lot numbers 24ALA613, exp. 3/31/2025; 23KLA748, 1/31/2025; 23KLA017, exp. 1/31/2025; 23JLA853, exp. 1/31/2025; 23JLA232. exp. 1/31/2025; 23ILB006, exp. 1/31/2025; 23ILA201, exp. 12/31/2024; and 23HLA429, exp. 12/31/2024; UDI-DI each-10193489816525 and UDI-DI case-40193489816526. e. Pack #DYNJ80649B - lot number 23JBG046, exp. 5/31/2026, UDI-DI each-10195327269944 and UDI-DI case-40195327269945.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 6 of 9

Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.

Z-2229-2024
Recall number
Z-2229-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
7,673 total non-sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

a. Pack #DYNJ901130I - Lot numbers 23GMH075, exp. 7/31/2024, and 23GMD605, exp. 7/31/2024, UDI-DI each-10193489946055 and UDI-DI case-40193489946056. b. Pack DYNJ902938J - Lot numbers 23LMD530, 23IMG375, 23HMB336, 23GMF342, 23EMJ935, and 23EMK254, all exp. date 8/31/2024, UDI-DI each-10193489946116, UDI-DI case 40193489946117.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 7 of 9

Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. c. Medline Intubation Tray (Adult), Pack #DYNJAA245A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. d. Medline Adult Main Disp. Intub Part A, Pack #DYNJAA262A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. e. Medline Adult Anesthesia Tray, Pack #DYNJAA276, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. f. Medline Baby Care Kit, Pack #DYKL1025 and Pack #DYKL1025H, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.

Z-2230-2024
Recall number
Z-2230-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
7,673 total non-sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

a. Pack #ACC010578 - Lot number 24ADA089, exp. 12/31/2024, UDI-DI each-10195327085605 and UDI-DI case 40195327085606. b. Pack #ACC010616 and Pack #ACC010616H - Lot numbers 23IDA976, exp. 10/31/2024; 23IDA980, exp. 11/30/2024; 23HDA517, exp. 9/30/2024; and 23DDB062, exp. 4/30/2024. c. Pack #DYNJASA245A - Lot number 23JBT059, exp. 4/30/2025, UDI-DI each-10193489804584 and UDI-DI case-40193489804585. d. Pack #DYNJAA262A - Lot number 23GBJ039, exp. 9/30/2024, UDI-DI each-10195327208172 and UDI-DI case-40195327208173. e. Pack #DYNJAA276 - Lot number 23GBG661, exp. 8/31/2024, UDI-DI each-10195327338534 and UDI-DI case-40195327338535. f. Pack #DYKL1025 and Pack #DYKL1025H - Lot numbers 24ABY293, exp. 3/31/2026; 23LBD262, exp. 9/30/2024; 23IBN598, exp. 7/31/2024; 23GBF800, 8/31/2025; 23FBI255, exp. 2/28/2025, and 23CBT397, exp. 11/30/2024.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 8 of 9

Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.

Z-2231-2024
Recall number
Z-2231-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
7,673 total non-sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

Pack #CDS981759C - Lot numbers 24ADA460, exp. 7/31/2025; 23KDB724, exp. 7/31/2025; 23JDA205, exp. 10/31/2025; 23IDA683, exp. 11/30/2025; and 23EDA124, exp. 5/31/2025; UDI-DI each-10888277524002 and UDI-DI case-5/31/2025.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

device · product 9 of 9

Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Code Cart Drawer 2 Adlt Peds, Pack #ACC010366A, containing a Pure Pouch component DYNJ04048, Kelly Forceps/STD STR Sterile. d. Medline Drawer 2, Pack #ACC010375A, containing a Pure Pouch component Reorder #TRI67630, Sterile Straight Mayo Scissors, 5.5" and Sterile Magill Forceps, Reorder #66790. e. Medline Adult Drawer 4, Pack #ACC010389C, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. f. Medline Code Cart Drawer 1 Adult Airwa, Pack #ACC010451A, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. g. Medline Emergency Airway Drawer, Pack #ACC010492, containing a Pure Pouch component Sterile Magill Forceps, Reorder #66790. h. Medline Drawer 2, Pack #ACC010681, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile and Sterile Magill Forceps, Reorder #66790. i. Medline Drawer 2, Pack #ACC010690, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. j. Medline Drawer Two #IMF 109694, Pack #ACCVB1000A, containing a Pure Pouch component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. k. Medline First Hlth Moore Bronchoscopy, Pack #DYK1015098B4, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. l. Medline Trunk Kit 1EA, Pack #DYKM2013A, containing a Pure Pouch component #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Difficult Kit, Pack #DYKM2135, containing a Pure Pouch component Sterile Curved Kelly Hemostat, Reorder #66175 and Sterile Magill Forceps, Reorder #66790. n. Medline Wound Care Kit, Pack #DYNDW1033B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile.

Z-2232-2024
Recall number
Z-2232-2024
Initiated
March 14, 2024
Classification
Class II
Status
Ongoing
Quantity
7,673 total non-sterile kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

Code information

a. Pack #ACC010254B - Lot numbers 23KDB117, exp. 11/3/2024, and 23GDC173, exp. 6/30/2024, UDI-DI each-10193489651683 and UDI-DI case-40193489651684. b. Pack ACC010365A - Lot number23EDA386, exp. 12/31/2024, UDI-DI each 10195327063245 and UDI-DI case-40195327063246. c. Pack #ACC010366A - Lot number 23EDB861, exp. 1/31/2024, UDI-DI each 10195327063252 and UDI-DI case 40195327063253. d. Pack #ACC010375A - Lot numbers 23LDB985, exp. 6/30/2025; 23HDB243, exp. 3/31/2024, UDI-DI each-10193489890983 and UDI-DI case-40193489890984. e. Pack #ACC010389C - Lot numbers 24ADB277, exp. 3/31/2025; 23LDA035, exp. 3/31/2025; and 23HDC448, exp. 6/30/2024, UDI-DI each 10193489472493 and UDI-DI case-40193489472494. f. Pack #ACC010451A - Lot number 23HDB718, exp. 3/31/2025, UDI-DI each 10193489844849 and UDI-DI case 40193489844840. g. Pack #ACC010492 - Lot numbers 23IDA433, exp. 6/30/2024; 23HDC689, exp. 6/30/2024; and 23HDA419, exp. 5/30/2024; UDI-DI each-10193489481983 and UDI-DI case 40193489481984. h. Pack #ACC010681 - Lot numbers 24ADA608, exp. 7/31/2025; and 23HDB308, exp. 6/30/2025, UDI-DI each 10195327399665 and UDI-DI case-40195327399666. i. Pack #ACC010690 - Lot number 23IDB053, exp. 6/30/2024, UDI-DI each 10195327433307 and UDI-DI case-40195327433308. j. Pack #ACCVB1000A - Lot numbers 24ADB906, exp. 12/31/2024; 23KDC115, exp. 2/28/2025; 23IDB740, exp. 6/30/2024; and 23EDA442, ex. 5/31/2024; UDI-DI each-10195327345884 and UDI-DI case-40195327345885. k. Pack #DYK1015098B4 - Lot numbers 23IBA570, exp. 8/31/2026, and 23GBP526, exp. 8/31/2026, UDI-DI each 10884389250853 and UDI-DI case 40884389250854. l. Pack #DYKM2013A - Lot numbers 23KBH011, 23IBJ540, 23HBP844, 23HBE308, 23GBT102, and 23FBS539, all with exp. dates of 7/31/2024, UDI-DI each-10195327419868 and UDI-DI case-40195327419869. m. Pack #DYKM2135 - Lot numbers 24ABP810, 23EBJ055, and 23DBH351, all with exp. dates of 8/31/2025, UDI-DI each-10195327075798 and UDI-DI case-40195327075799. n. Pack #DYNDW1033B - Lot numbers 23LME845, exp. 4/30/2025; 23KMD933, exp. 4/30/2025, and 23GMF688, exp. 1/31/2025, UDI-DI each-10888277079182 and UDI-DI case-40888277079183.

Distribution pattern

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.