MEDLINE INDUSTRIES, LP - Northfield: Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN P

Hazard

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Details from the source

Reason for recall: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama. Quantity: 88 units Lot/code info: a) REF DYNJ46730, UDI/DI 40888277597199 (each), 10888277597198 (case), Lot Numbers: 23LBP056; b) REF DYNJ49302A, UDI/DI 40888277843395 (each), 10888277843394 (case), Lot Numbers: 24ABG706; c) REF DYNJ57526A, UDI/DI 40193489630931 (each), 10193489630930 (case), Lot Numbers: 23LBL679; d) REF DYNJ68750, UDI/DI 40193489836586 (each), 10193489836585 (case), Lot Numbers: 24ABB984

UPC codes

40888277597199, 10888277597198, 40888277843395, 10888277843394, 40193489630931, 10193489630930, 40193489836586, 10193489836585

Source

Official record: FDA (Device enforcement) ↗

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