FDA Recall
Open, Classified
NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
Recall: Z-1554-2022
·
Initiated July 25, 2022
Recall
- Recall Number
- Z-1554-2022
- Event Number
- 90668
- Firm
- Stradis Medical, LLC dba Stradis Healthcare
- FEI Number
- 1000111025
- Product Code
- HTD
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- July 25, 2022
- Address
- 3025 Northwoods Pkwy, Peachtree Corners, GA, 30071-1524
Description
NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
Reason
The sterile barrier may be compromised.
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.
Distribution
US Nationwide distribution in the state of SC.
Quantity
850 units