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U.S. Department of Health and Human Services

Class 2 Device Recall Genzyme Biosurgery Essentials Kit, Item Number 82004

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  Class 2 Device Recall Genzyme Biosurgery Essentials Kit, Item Number 82004 see related information
Date Initiated by Firm July 13, 2010
Date Posted August 28, 2010
Recall Status1 Terminated 3 on January 30, 2012
Recall Number Z-2310-2010
Recall Event ID 56218
Product Classification General Surgery Tray - Product Code LRO
Product Genzyme Biosurgery Essentials Kit, Item Number 82004
Code Information Lot Numbers Affected: RM00654  RM00664  RM00672  RM00687  RM00690  RM00698  RM00700  RM00711  RM00714  RM00727  RM00732  RM00741  RM00748  RM00757  RM00773  RM00781  RM00791  RM00802 RM00820 RM00835
Recalling Firm/
Manufacturer		 Genzyme Corporation
64 Sidney Street
Cambridge MA 02139
For Additional Information Contact
617-252-7999
Manufacturer Reason
for Recall		 Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.
FDA Determined
Cause 2		 Labeling design
Action Genzyme notiifed physicians with the Dear Doctor letter on July 13, 2010 via UPS Ground delivery. The letter informed healthcare workers of the recent incidents and advise them to heed the Essentials Kit label and exercise proper handling of the Kit.. A fax return form will be provided for the physician to sign and return to Genzyme to acknowledge receipt of the notification. Contact Genzyme Medical Information at 800-453-6948, option #3 for any additional information or contact your Genzyme sales representative with any questions.
Quantity in Commerce 3132 kits
Distribution Nationwide
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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