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U.S. Department of Health and Human Services

Class 2 Device Recall CQUR Mesh

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  Class 2 Device Recall CQUR Mesh see related information
Date Initiated by Firm July 19, 2013
Date Posted August 09, 2013
Recall Status1 Terminated 3 on March 18, 2016
Recall Number Z-1936-2013
Recall Event ID 65698
510(K)Number K050311  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product C-QUR Mesh (All Sizes, shapes).

Intended for use in soft tissue deficiencies.
Code Information Product lines with lot number 10405513 and higher
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
For Additional Information Contact same
603-880-1433
Manufacturer Reason
for Recall		 Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
FDA Determined
Cause 2		 Package design/selection
Action Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification. Additional language to the instructions for use (IFU) to include: Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable. Questions please contact Atrium Medical Customer Service at 1- 800- 528-7486 Monday through Friday 9:00 am to 5:00 pm EDT.
Quantity in Commerce 32,834 units
Distribution USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
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.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = ATRIUM MEDICAL CORP.
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