Genzyme Biosurgery Essentials Kit, Item Number 82004
- Company
- Genzyme Corporation
- Recall Initiated
- July 13, 2010
- Posted
- August 28, 2010
- Terminated
- January 30, 2012
- Recall Number
- Z-2310-2010
- Quantity
- 3132 kits
- Firm Location
- Cambridge, MA
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.
Distribution
Nationwide
Lot / Code Info
Lot Numbers Affected: RM00654 RM00664 RM00672 RM00687 RM00690 RM00698 RM00700 RM00711 RM00714 RM00727 RM00732 RM00741 RM00748 RM00757 RM00773 RM00781 RM00791 RM00802 RM00820 RM00835
Root Cause
Labeling design
Action Taken
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.