Reported Jul 10, 2024 · Ongoing

Sterile surgical convenience kits

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

Sterile surgical convenience kits

24 of 24 products

Products covered by this recall
#Product as published
1Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
2Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
3Medline Heart Catheterization Pack, Pack #DYNJ30927Q, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
4Medline Heart Catheterization Pack, Pack #DYNJ30927R, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
5Medline Minor Special Procedure Pack, Pack #DYNJ38326G, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
6Medline Perm Cath Tray, Pack #DYNJ40423A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
7Medline CRMC Angiogram-LF, Pack #DYNJ61082F, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
8Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099D, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970.
9Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099F, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970.
10Medline Cath Lab Pack, Pack #DYNJ81995, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
11Medline Cardiac Cath, Pack #DYNJ82907, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
12Medline Special Procedure Tray, Pack #DYNJ83626, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
13Medline Cath Lab Pack, Pack #DYNJ83924, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
14Medline Cath Lab Pack, Pack #DYNJ83924A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
15Medline Cath Pack, Pack #DYNJ84739, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
16Medline Cardiac Cath Pack, Pack #DYNJ85872, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000.
17Medline Pacemaker Pack, Pack #DYNJ55340C, containing a Pure Pouch with component Sterile Straight Kelly Hemostat, Reorder #66170.
18Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118G, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970.
19Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118I, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970.
20Medline Endovascular Pack, Pack #DYNJ66727B, containing a Pure Pouch with component Sterile 6" SnagFree Mayo Needle Holder, Reorder #66430.
Lot codes and dates

26 of 26 products

Products covered by this recall
#BarcodesProduct as published
11019532719561840195327195619Pack #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.
21019532720978040195327209781Pack #DYNJ26488W - lot number 23EDA461, exp. 10/31/2025, UDI-DI each-10195327209780, UDI-DI case-40195327209781.
31019532716422540195327164226Pack #DYNJ30927Q - lot numbers 23IMB725, exp. 4/30/2026, and 23GMI473, exp. 1/31/2026, UDI-DI each-10195327164225, UDI-DI case-40195327164226.
41019532753916040195327539161Pack #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.
51019532723013540195327230136Pack #DYNJ38326G - lot numbers 23KMB384, exp. 5/3/2025, and 23HME988, exp. 5/31/2025, UDI-DI each 10195327230135, UDI-DI case-40195327230136.
61088994234699840889942346999Pack #DYNJ4423A - lot number 23JBC229, exp. 8/31/2027, UDI-DI each-10889942346998, UDI-DI case-40889942346999.
71019532745178340195327451784Pack #DYNJ61082F - lot numbers 23HMG768, exp. 3/31/2026, UDI-DI each-10195327451783, UDI-DI case-40195327451784.
81019532745179040195327451791Pack #DYNJ61099D - lot numbers 23JBN632, exp. 1/31/2026, UDI-DI each-10195327451790, UDI-DI case-40195327451791.
91019532756192540195327561926Pack #DYNJ61099F - lot numbers 24ABB295, exp. 4/30/2026, UDI-DI each-10195327561925, UDI-DI case-40195327561926.
101019532716347140195327163472Pack #DYNJ81995 - lot numbers 23JMA624, exp. 8/31/2026, and 23GME739, exp. 4/30/2026, UDI-DI each-10195327163471, UDI-DI case 40195327163472.
111019532716970140195327169702Pack #DYNJ82097 - lot number 23GME848, exp. 7/31/2025, UDI-DI each-10195327169701, UDI-DI case-40195327169702.
121019532728687340195327286874Pack #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.
131019532731483540195327314836Pack #DYNJ83924 - lot numbers 23FBH281, exp. 7/31/2027, UDI-DI each-10195327314835, UDI-DI case-40195327314836.
141019532750720640195327507207Pack #DYNJ83924A - lot numbers 23KBQ984, exp. 1/31/2028, and 23KBN818, exp. 1/31/2028, UDI-DI each-10195327507206, UDI-DI case-40195327507207.
151019532740927240195327409273Pack DYNJ84739 - lot numbers 23KMG773, exp. 8/31/2026, and 23JMB674, exp. 2/28/2025, UDI-DI each-10195327409272, UDI-DI case-40195327409273.
161019532756272440195327562725Pack DYNJ85872 - lot number 24BBB337, exp. 9/30/2026, UDI-DI each-10195327562724, UDI-DI case-40195327562725.
171019532735291240195327352913Pack DYNJ55340C - lot number 23FMC559, exp. 9/30/2025, UDI-DI each-10195327352912, UDI-DI case 40195327352913.
181019532745174540195327451746Pack #DYNJ61118G - lot numbers 23JME718, exp. 5/31/2025, and 23GME956, exp. 5/31/2026, UDI-DI each-10195327451745, UDI-DI case-40195327451746.
191019532756191840195327561919Pack #DYNJ61118I - lot number 23KMG830, exp. 5/31/2025, UDI-DI each-10195327561918, UDI-DI case 40195327561919.
201019532729908840195327299089Pack #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.
Amount recalled
12,588 total sterile kits

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

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