Date Initiated by Firm |
September 30, 2011 |
Date Posted |
September 20, 2012 |
Recall Status1 |
Terminated 3 on April 29, 2013 |
Recall Number |
Z-2352-2012 |
Recall Event ID |
62132 |
Product Classification |
General surgery tray (kit) - Product Code LRO
|
Product |
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution
Product Usage: Usage: The PVP contained in the kit is used in skin prep
|
Code Information |
14161-0901 |
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 |
3 cases |
Distribution |
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA. |
Total Product Life Cycle |
TPLC Device Report
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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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