Device product
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Z-1779-2022
Product summary
- Event
- Event 90834
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53,560 units
- Official record key
device-enforcement:Z-1779-2022
Official wording
Reason: 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.
Code information: UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11
Distribution pattern: Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Derived failure modes
-
Sterility assurance
lack of sterility