Class II Recall

Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch

Summary

The FDA issued a Class II for Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pa by MEDLINE INDUSTRIES, LP - Northfield. Reason: 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 fa.

Details

Source

Device Recall

External ID

Z-2224-2024

Action Date

2024-07-10

Status

Ongoing

Product Description

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.

Lot/Code Info: 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.

Quantity Affected: 12,588 total sterile kits

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.

Distribution

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-03-14

Company

MEDLINE INDUSTRIES, LP - Northfield

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?

MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2224-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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