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.
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
10193489445541, 10884389097458, 40889942436348, 40884389914657, 40653160992746
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.