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: 1588 units Lot/code info: a) Reorder Number DT21400, GTIN 40653160318225 Lot # 22HMH962; b) Reorder Number DT22255, GTIN 40653160328644 Lot # 22HMH427; c) Reorder Number DYNDC1022GB, GTIN 40195327038701 Lot # 22GBY236
40653160318225, 40653160328644, 40195327038701
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.