Device product
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Z-2357-2012
Product summary
- Event
- Event 62132
- Status
- Terminated
- Classification
- Class I
- Quantity
- 538 cases
- Official record key
device-enforcement:Z-2357-2012
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: 16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004
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.