Z-1040-2022 Class II Ongoing
FDA device recall Z-1040-2022 was initiated by American Contract Systems, Inc. on Mar 22, 2022 and is designated Class II. Reason for recall: Product was sterilized with a higher than specification EO concentration. The recall status is ongoing. Affected quantity: 10 packs.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- Mar 22, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1040-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026