Z-1779-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- September 8, 2022
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,560 units
Product Description
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
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 Pattern
Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
Code Information
UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11