Device product
CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Z-2359-2012
Product summary
- Event
- Event 62132
- Status
- Terminated
- Classification
- Class I
- Quantity
- 8 cases
- Official record key
device-enforcement:Z-2359-2012
Official wording
Reason: The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Code information: 19850-1006
Distribution pattern: US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Derived failure modes
-
Unknown
The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.