Recall Z-2717-2014 ยท GFD Dermatome
KCI USA, Inc.
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
| Date | Sep 29, 2014 (initiated May 19, 2014) |
| Status | Terminated |
| Reason | Blade can shift during shipping which makes the product ineffective. |
| Root cause | Device Design |
| Action | KCI sent an Urgent - Voluntary Medical Device Field Notification letter dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is sending Field Notifications to affected customers instructing them to complete appropriate actions. Option I: Contact your local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected harvester(s). Option 2: If you prefer, you may re-set the blade after removal from the packag |
| Quantity | 1,331 units |
| Distribution | US nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.