Recall Z-1553-2022 ยท HTD Forceps
Stradis Medical, LLC dba Stradis Healthcare
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
| Date | Jul 25, 2022 |
| Status | Open, Classified |
| Reason | The sterile barrier may be compromised. |
| Root cause | Under Investigation by firm |
| Action | Stradis notified its sole consignee on 07/25/2022 by email. The notice explained the reason for the recall and the hazard, and requested the consignee contact customer service to arrange for the return and credit of the affected product. Should the product be further distributed, the consignee was directed to notify its customers within 48 hours of receipt of the notice. Those customers were directed to contact Stradis directly to arrange return and credit. |
| Quantity | 825 units |
| Distribution | US Nationwide distribution in the state of SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.