Z-1040-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- March 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 packs
Product Description
ACS Cath Lab Pack
Reason for Recall
Product was sterilized with a higher than specification EO concentration.
Distribution Pattern
US Nationwide distribution in the states of IL, MO, NE, and TX.
Code Information
Model FTCL83K, Lot 982221 UDI: 00191072151360