Recall Z-1036-2022— American Contract Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems, Inc., initiated 2022-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray. Reason: Product was sterilized with a higher than specification EO concentration..
- Recalling firm
- American Contract Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-22
- Firm location
- Kansas City, MO, United States
Product description
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Reason for recall
Product was sterilized with a higher than specification EO concentration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.