MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2025 - (Recall #: Z-1594-2025)

Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 5) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 6) PHLEBECTOMY PACK, Model Number: DYNJ55215G; 7) BIOPSY/DRAINAGE TRAY-LF, Model Number: DYNJ30078D; 8) CAT BIOPSY PACK, Model Number: DYNJ62968; 9) ABLATION/DRAINAGE PACK, Model Number: DYNJ53658D; 10) BIOPSY KIT, Model Number: DYNJ61130B

Class II

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

1) DYNJ68393A, UDI-DI: 10193489939996(each), 40193489939997(case), Lot Number: 24IBP745; 2) DYNJ81441B, UDI-DI: 10198459111105(each), 40198459111106(case), Lot Number: 24JBB770; 3) DYNJ68303, UDI-DI: 10193489821529(each), 40193489821520(case), Lot Number: 24JBU406; 4) DYNJ41678B, UDI-DI: 10198459124129(each), 40198459124120(case), Lot Number: 24JBW438; 5) DYNJ41678B, UDI-DI: 10198459124129(each), 40198459124120(case), Lot Number: 24JBW452; 6) DYNJ55215G, UDI-DI: 10193489925555(each), 40193489925556(case), Lot Number: 24KBC666; 7) DYNJ30078D, UDI-DI: 10889942138647(each), 40889942138648(case), Lot Number: 24KBD430; 8) DYNJ62968, UDI-DI: 10193489706239(each), 40193489706230(case), Lot Number: 24KBE699; 9) DYNJ53658D, UDI-DI: 10195327672140(each), 40195327672141(case), Lot Number: 24KBF023; 10) DYNJ61130B, UDI-DI: 10195327054588(each), 40195327054589(case), Lot Number: 24KBG714

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Voluntary: Firm initiated