CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram T...
FDA Recall #Z-2331-2012 — Class II — September 30, 2011
Product 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 for Recall
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.
Recalling Firm
Custom Medical Specialties, Inc. — Pine Level, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 cases
Distribution
Nationwide Distribution including GA, MI, NY, and PA.
Code Information
14327-0902, 19929-1006
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated