Medical device recalls Moderate risk

Terumo BCT, Inc. recalls Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

Recall date
November 3, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0674-2017
FDA classification
Class II
Brand / firm
Terumo BCT, Inc.
Sold / distributed
Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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