Recall Z-2167-2020 ยท FBO Cystourethroscope
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
| Date | Apr 13, 2020 |
| Status | Terminated |
| Reason | The surgical gowns were manufactured in a facility that is not registered by the FDA. |
| Root cause | Process control |
| Action | Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal. |
| Quantity | 2,868 total kits |
| Distribution | US Nationwide distribution including in the state of Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.