FDA Device

Genzyme Biosurgery Essentials Kit, Item Number 82004

Hazard

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.

What You Should Do

Remedy

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.

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Products

Genzyme Biosurgery Essentials Kit, Item Number 82004
Brand
Genzyme Corporation
UPC
Lot Numbers Affected: RM00654  RM00664  RM00672  RM00687  RM00690  RM00698  RM00700  RM00711  RM00714  RM00727  RM00732  RM00741  RM00748  RM00757  RM00773  RM00781  RM00791  RM00802 RM00820 RM00835

Units Affected

3132 kits

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