Terumo BCT, Inc. recalls HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

Recall date

October 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0104-2018

FDA classification

Class II

Brand / firm

Terumo BCT, Inc.

Sold / distributed

CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain

Why it was recalled

The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expiration noted was not beyond initiation date of the recall. Since the product is noted as sterile, the clearance for K103340, K052925 and K991430 raises question if product was cleared with a sterility claim. Further post-market follow-up will be required to assess the safety risk of the product.

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

What was recalled

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO