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U.S. Department of Health and Human Services

Class 2 Device Recall Hemashield Double Velour Cardiovascular Fabrics.

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  Class 2 Device Recall Hemashield Double Velour Cardiovascular Fabrics. see related information
Date Initiated by Firm May 24, 2010
Date Posted July 22, 2010
Recall Status1 Terminated 3 on July 14, 2011
Recall Number Z-2062-2010
Recall Event ID 56004
510(K)Number K955349  
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
Product Hemashield Double Velour Cardiovascular Fabrics.
Code Information xxx
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Susan Eichler Huston
973-709-7487
Manufacturer Reason
for Recall		 Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.
FDA Determined
Cause 2		 Package design/selection
Action Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.
Quantity in Commerce xx
Distribution Nationwide Distribution.
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 = DXZ and Original Applicant = MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
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