Device product
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Z-2328-2012
Product summary
- Event
- Event 62875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases
- Official record key
device-enforcement:Z-2328-2012
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: 19207-1004
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.