FDA Enforcement
Class II
Ongoing
ACS Cath Lab Pack
Recall: Z-1040-2022
·
Reported May 18, 2022
Enforcement
- Recall Number
- Z-1040-2022
- Event ID
- 89868
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- American Contract Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 18, 2022
- Initiation Date
- March 22, 2022
- Classification Date
- May 6, 2022
- Address
- 2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States
Description
ACS Cath Lab Pack
Reason
Product was sterilized with a higher than specification EO concentration.
Code Info
Model FTCL83K, Lot 982221 UDI: 00191072151360
Distribution
US Nationwide distribution in the states of IL, MO, NE, and TX.
Quantity
10 packs