Non-sterile convenience kits: a. Medline CC Drawer 4 IV recall: Sterility Concern
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B…
Why was Non-sterile convenience kits: a. Medline CC Drawer 4 IV 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 7,673 total non-sterile kits
- 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.
- Recall date
- July 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)