Recall Z-2310-2010 ยท LRO General Surgery Tray
Genzyme Corporation
Genzyme Biosurgery Essentials Kit, Item Number 82004
| Date | Aug 28, 2010 (initiated Jul 13, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 3132 kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.