Device product
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Z-2331-2012
Product summary
- Event
- Event 62875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 cases
- Official record key
device-enforcement:Z-2331-2012
Official wording
Reason: The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
Code information: 14327-0902, 19929-1006
Distribution pattern: Nationwide Distribution including GA, MI, NY, and PA.
Derived failure modes
-
Unknown
The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.