Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.
FDA device recall Z-0674-2017 · posted 2016-11-30 · Terminated
Recall details
- Recalling firm
- Terumo BCT, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MUU
- Quantity affected
- 660
- Distribution
- Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
- Date initiated
- 2016-11-03
- Date posted
- 2016-11-30
- Date terminated
- 2017-03-02
- Location
- Lakewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADIPREP ADIPOSE TRANSFER SYSTEM (K121005) | Harvest Technologies, Corp. | 2012-09-21 |