BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Produc...
FDA Recall #Z-2360-2012 — Class I — September 30, 2011
Product Description
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 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
75 cases & 60 Bottles for reps
Distribution
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Code Information
14255-0901
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated