FDA Recall
Terminated
Restrata, Part Number RWM1-2X2
Recall: Z-1030-2022
·
Initiated March 21, 2022
Recall
- Recall Number
- Z-1030-2022
- Event Number
- 89919
- Firm
- Acera Surgical Inc
- FEI Number
- 3012429393
- Product Code
- FRO
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 21, 2022
- Terminated
- August 20, 2024
- Address
- 7842 Hickory Flat Hwy, Ste B, Woodstock, GA, 30188-6579
Description
Restrata, Part Number RWM1-2X2
Reason
Misprinted expiration date on the shelf-box
Action
The firm initiated the recall by letter, either hand delivered or via certified mail, beginning on 03/21/2022. The notice explained the problem and requested return of the product.
Distribution
Nationwide
Quantity
83 units