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Terminated

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

FDA Recall Z-0674-2017 · Posted 2016-11-30

Recalling FirmTerumo BCT, Inc.
Recall StatusTerminated
Product CodeMUU
Date Initiated2016-11-03
Date Terminated2017-03-02
Product Quantity660

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.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121005ADIPREP ADIPOSE TRANSFER SYSTEMHarvest Technologies, Corp. · 2012-09-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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