MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GY

Hazard

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

Details from the source

Reason for recall: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands. Quantity: 706 units 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

UPC codes

10193489974089, 40193489974080, 10888277801905, 40888277801906, 10195327057381, 40195327057382, 10195327680145, 40195327680146, 10193489845594, 40193489845595, 10193489458695, 40193489458696, 10193489905434, 40193489905435, 10198459124228, 40198459124229, 10193489391640, 40193489391641, 10195327547134, 40195327547135, 10195327679644, 40195327679645, 10193489326161, 40193489326162, 10195327258023, 40195327258024, 10198459187216, 40198459187217

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.