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U.S. Department of Health and Human Services

Class 2 Device Recall PVP Prep Solution

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  Class 2 Device Recall PVP Prep Solution see related information
Date Initiated by Firm September 30, 2011
Date Posted September 07, 2012
Recall Status1 Terminated 3 on September 10, 2012
Recall Number Z-2331-2012
Recall Event ID 62875
Product Classification Tray, surgical - Product Code LRP
Product CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution

CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Code Information 14327-0902, 19929-1006
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 15 cases
Distribution Nationwide Distribution including GA, MI, NY, 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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