Recall Z-1688-2022 ยท OXQ Dressing Change Tray
Stradis Healthcare
VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
| Date | May 10, 2022 |
| Status | Open, Classified |
| Reason | Potential for incomplete seals. |
| Root cause | Other |
| Action | Stradis notified its sole consignee initially by telephone on 05/10/2022 and followed with a letter disseminated by email on 05/11/2022. The letter explained the problem, risk to health, and requested the quarantine of the affected product pending return. The letter directed the consignee to notify their customers to whom they further distributed the product to return the product to Stradis. |
| Quantity | 520 units |
| Distribution | Pennsylvania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.