FDA Device recall Z-2232-2024

Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Sc…

FDA Device
Class II
ongoing
Published 2024-07-10

On 2024-07-10 the FDA classified a Class II recall of Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Sc… by Medline Industries Northfield, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2232-2024
Classification	Class II
Status	ongoing
Initiated	2024-03-14
Published	2024-07-10
Last updated	2026-09-13 11:57 UTC
Company	Medline Industries Northfield
Distribution	US

Product

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.

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 fails.

Identifiers

code_info	a. Pack #ACC010254B - Lot numbers 23KDB117, exp. 11/3/2024, and 23GDC173, exp. 6/30/2024, UDI-DI each-10193489651683 a… 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 40193489

code_info

a. Pack #ACC010254B - Lot numbers 23KDB117, exp. 11/3/2024, and 23GDC173, exp. 6/30/2024, UDI-DI each-10193489651683 a…

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 40193489

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2232-2024%22

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