Recall Z-0674-2017 ยท MUU System, Suction, Lipoplasty
Terumo BCT, Inc.
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
| Date | Nov 30, 2016 (initiated Nov 3, 2016) |
| Status | Terminated |
| Reason | Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion. |
| Root cause | Error in labeling |
| Action | Consignees will be notified on 11/07/16 via letter to contact the North America Terumo BCT support center at +1.877.842.7837 or +1.303.542.5050 if they have any affected product to issue a Return Goods Authorization for product return. |
| Quantity | 660 |
| Distribution | Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121005 | ADIPREP ADIPOSE TRANSFER SYSTEM Harvest Technologies, Corp., Sep 21, 2012 |