FDA Enforcement
Class II
Terminated
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Recall: Z-2331-2012
·
Reported September 19, 2012
Enforcement
- Recall Number
- Z-2331-2012
- Event ID
- 62875
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Custom Medical Specialties, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 19, 2012
- Initiation Date
- September 30, 2011
- Classification Date
- September 7, 2012
- Termination Date
- September 10, 2012
- Address
- 330 East Main Street, N/A, Pine Level, NC, 27568, United States
Description
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
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 Info
14327-0902, 19929-1006
Distribution
Nationwide Distribution including GA, MI, NY, and PA.
Quantity
15 cases