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FDA (Device enforcement)Recalled 2022-12-07class ii

MEDLINE INDUSTRIES, LP - Northfield: Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLIN

Hazard

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Details from the source

Reason for recall: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. Distribution: Nationwide Quantity: 4779 units Lot/code info: a) Reorder Number DYNJ67850, GTIN 10193489445541, Lot # 22BBJ239; b) Reorder Number DYNJSHOULDER2, GTIN 10884389097458, Lot # 22DBN344; c) Reorder Number P429589A, GTIN 40889942436348, Lot # 22HME367; d) Reorder Number SPEC0177, GTIN 40884389914657, Lot # 22MBA770; e) Reorder Number PT235A, GTIN 40653160992746, Lot # 22HMH321

UPC codes

10193489445541, 10884389097458, 40889942436348, 40884389914657, 40653160992746

Source

Official record: FDA (Device enforcement)

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

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