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
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Product | Hemashield Double Velour Cardiovascular Fabrics. |
Code Information |
xxx |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular, LLC 45 Barbour Pond Dr Wayne NJ 07470-2094
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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 |
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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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510(K) Database | 510(K)s with Product Code = DXZ
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