Device product
CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Z-2355-2012
Product summary
- Event
- Event 62132
- Status
- Terminated
- Classification
- Class I
- Quantity
- 195 cases
- Official record key
device-enforcement:Z-2355-2012
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: 14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, 18829-1003
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.