Recall Z-1554-2022
Stradis Medical, LLC dba Stradis Healthcare · initiated July 25, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
Codes / lots: SKU/Part Number: ZZ-0701; Lots: 22027483172 and 22131487071 UDI/DI: M752ZZ07010
Reason for recall
The sterile barrier may be compromised.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1554-2022
- Initiated
- July 25, 2022
- Product code
- HTD – Forceps
- Quantity
- 850 units
- Distribution
- US Nationwide distribution in the state of SC.
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1552-2022 Class II | NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697The sterile barrier may be compromised. | 07/25/2022Open, Classified |
| Z-1553-2022 Class II | NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700The sterile barrier may be compromised. | 07/25/2022Open, Classified |