Recall Z-2167-2020— American Contract Systems
Class II · Terminated
Class II FDA medical device recall by American Contract Systems, initiated 2020-04-13, terminated 2020-11-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile Custom Packs to be used in surgical procedures.. Reason: The surgical gowns were manufactured in a facility that is not registered by the FDA..
- Recalling firm
- American Contract Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-13
- Terminated
- 2020-11-25
- Firm location
- Zelienople, PA, United States
Product description
Sterile Custom Packs to be used in surgical procedures.
Reason for recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.