Device product
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Z-2329-2012
Product summary
- Event
- Event 62875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 cases
- Official record key
device-enforcement:Z-2329-2012
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: 16480-0908, 20976-1008, 21283-1009
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.