Z-1693-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- June 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Various ENT Packs
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Distribution Pattern
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Code Information
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPENTLHA, 2106181, 838211, 14882942 2) MREN03G, 2104262, 887211, 14934943 3) COEN27K, 2108102, 779211, 15093749-004