The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.
Reason for recall: The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle. Distribution: Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX. Quantity: 53,560 units Lot/code info: UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11
00709078004483, 10709078004480
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.