CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP c...
FDA Recall #Z-2349-2012 — Class I — September 30, 2011
Product Description
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP 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 of the Povidone Iodine Prep Solution 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 I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
5 cases
Distribution
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Code Information
20182-1006
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated