FDA Enforcement
Class II
Terminated
Restrata, Part Number RWM1-2X2
Recall: Z-1030-2022
·
Reported May 11, 2022
Enforcement
- Recall Number
- Z-1030-2022
- Event ID
- 89919
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Acera Surgical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 11, 2022
- Initiation Date
- March 21, 2022
- Classification Date
- May 2, 2022
- Termination Date
- August 20, 2024
- Address
- 7842 Hickory Flat Hwy Ste B, N/A, Woodstock, GA, 30188-6579, United States
Description
Restrata, Part Number RWM1-2X2
Reason
Misprinted expiration date on the shelf-box
Code Info
Lot Number 51745 UDI (01) 8 52425800 60682 (10) 51745 (17) 220218 (21) 0068
Distribution
Nationwide
Quantity
83 units