Recall Z-0674-2017— Terumo BCT, Inc.

Name: FDA recall Z-0674-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-03

Class II · Terminated

Class II FDA medical device recall by Terumo BCT, Inc., initiated 2016-11-03, terminated 2017-03-02. It names one FDA 510(k) clearance: K121005. Product: Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.. 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..

Recalling firm: Terumo BCT, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-03
Terminated: 2017-03-02
Firm location: Lakewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K121005 — ADIPREP ADIPOSE TRANSFER SYSTEMHarvest Technologies, Corp.·cleared 2012-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.