medical Class II Updated 2025-04-23

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) ST

Recalled Product

Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE LITHOMIE MINEURE-LF, Model Number: DYNJ47552C; 6) CH D&C PACK, Model Number: DYNJ67945; 7) LAP GYN PACK-LF, Model Number: DYNJ25892K; 8) GYN LAPAROSCOPY PACK BJC-LF, Model Number: DYNJ41670B; 9) OPP GYN VAGINAL PACK, Model Number: DYNJ67227; 10) GYNE MINOR LAPAROSCOPY GRH-LF, Model Number: DYNJ41790F; 11) GYNE - LITHOTOMY MINOR PACK-LF, Model Number: DYNJ49251C; 12) STANDARD D&C, Model Number: DYNJ69733; 13) PERI GYN PACK, Model Number: DYNJ24338I; 14) GYN LAPAROSCOPY CDS, Model Number: CDS982727L; 15) ROBOTICS, Model Number: DYNJ908712B

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1) DYNJ69733, UDI-DI: 10193489974089(each), 40193489974080(case), Lot Number: 24IBE079; 2) DYNJ39904A, UDI-DI: 10888277801905(each), 40888277801906(case), Lot Number: 24IBF466; 3) DYNJ64651A, UDI-DI: 10195327057381(each), 40195327057382(case), Lot Number: 24IBS312; 4) DYNJ49250F, UDI-DI: 10195327680145(each), 40195327680146(case), Lot Number: 24JBM609; 5) DYNJ47552C, UDI-DI: 10193489845594(each), 40193489845595(case), Lot Number: 24JBN271; 6) DYNJ67945, UDI-DI: 10193489458695(each), 40193489458696(case), Lot Number: 24JBU691; 7) DYNJ25892K, UDI-DI: 10193489905434(each), 40193489905435(case), Lot Number: 24JBV586; 8) DYNJ41670B, UDI-DI: 10198459124228(each), 40198459124229(case), Lot Number: 24KBA786; 9) DYNJ67227, UDI-DI: 10193489391640(each), 40193489391641(case), Lot Number: 24KBC196; 10) DYNJ41790F, UDI-DI: 10195327547134(each), 40195327547135(case), Lot Number: 24KBC471; 11) DYNJ49251C, UDI-DI: 10195327679644(each), 40195327679645(case), Lot Number: 24KBG007; 12) DYNJ69733, UDI-DI: 10193489974089(each), 40193489974080(case), Lot Number: 24KBH831; 13) DYNJ24338I, UDI-DI: 10193489326161(each), 40193489326162(case), Lot Number: 24KBH862; 14) CDS982727L, UDI-DI: 10195327258023(each), 40195327258024(case), Lot Number: 24KBU700; 15) DYNJ908712B, UDI-DI: 10198459187216(each), 40198459187217(case), Lot Number: 24LBF830

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