FDA Recall
Open, Classified
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Recall: Z-0866-2022
·
Initiated February 25, 2022
Recall
- Recall Number
- Z-0866-2022
- Event Number
- 89671
- Firm
- Stradis Medical, LLC dba Stradis Healthcare
- FEI Number
- 1000111025
- Product Code
- OJH
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- February 25, 2022
- Address
- 3025 Northwoods Pkwy, Peachtree Corners, GA, 30071-1524
Description
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Reason
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Action
A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
Distribution
US Nationwide distribution in the states of IN, TX, and PA.
Quantity
348 units