CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used ...
FDA Recall #Z-2329-2012 — Class II — September 30, 2011
Product Description
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
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
16 cases
Distribution
Nationwide Distribution including GA, MI, NY, and PA.
Code Information
16480-0908, 20976-1008, 21283-1009
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated