CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in...
FDA Recall #Z-2328-2012 — Class II — September 30, 2011
Product Description
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution 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
3 cases
Distribution
Nationwide Distribution including GA, MI, NY, and PA.
Code Information
19207-1004
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated