FDA-Device2016-12-07Class II

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

Terumo BCT, Inc.
Hazard

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.

Sold states
Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.
Affected count
660
Manufactured in
10811 W Collins Ave, Lakewood, CO, United States
Products
Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0674-2017

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