Genzyme Biosurgery Essentials Kit, Item Number 82004

FDA device recall Z-2310-2010 · posted 2010-08-28 · Terminated

Recall details

Recalling firm

Genzyme Corporation

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.

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.

Root cause

Labeling design

Status

Terminated

Product code

LRO

Quantity affected

3132 kits

Distribution

Nationwide

Date initiated

2010-07-13

Date posted

2010-08-28

Date terminated

2012-01-30

Location

Cambridge, MA