Date Initiated by Firm |
September 30, 2011 |
Date Posted |
September 07, 2012 |
Recall Status1 |
Terminated 3 on September 10, 2012 |
Recall Number |
Z-2330-2012 |
Recall Event ID |
62875 |
Product Classification |
Tray, surgical - Product Code LRP
|
Product |
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution
The PV contained in the kit is used in skin prep |
Code Information |
20179-1006 |
Recalling Firm/ Manufacturer |
Custom Medical Specialties, Inc. 330 East Main Street Pine Level NC 27568
|
For Additional Information Contact |
Diane McAlinn 919-202-8462
|
Manufacturer Reason for Recall |
The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Custom Medical Specialties sent an Urgent Medical Device Recall letter dated August 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory for the affected product and to discontinue the use of any affected product. Customer were instructedto complete and return the Return Response form, acknowledging they have received the letter and checked their inventory. Any product still in the customers inventory should be returned to the firm. Customers should call (919) 202-8462, ext 205 to obtain a Return Authorization Number and the shipping number.
For questions regarding this recall call 919-202-8462. |
Quantity in Commerce |
4 cases |
Distribution |
Nationwide Distribution including GA, MI, NY, 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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