CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: ...
FDA Recall #Z-2356-2012 — Class I — September 30, 2011
Product Description
CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution 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 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
15 cases
Distribution
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Code Information
15924-0906, 16975-0910, 17709-0912
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated