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U.S. Department of Health and Human Services

Class 1 Device Recall PovidineIodine prep solution/Providine prep pads

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  Class 1 Device Recall PovidineIodine prep solution/Providine prep pads see related information
Date Initiated by Firm September 30, 2011
Date Posted September 20, 2012
Recall Status1 Terminated 3 on April 29, 2013
Recall Number Z-2360-2012
Recall Event ID 62132
Product Classification General surgery tray (kit) - Product Code LRO
Product 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
Code Information 14255-0901
Recalling Firm/
Manufacturer
Custom Medical Specialties, Inc.
330 East Main Street
Pine Level NC 27568
For Additional Information Contact Diane McAlinn
919-202-8462 Ext. 205
Manufacturer 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.
FDA Determined
Cause 2
Material/Component Contamination
Action Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
Quantity in Commerce 75 cases & 60 Bottles for reps
Distribution US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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