Terumo BCT, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0103-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

Product Classification:

Class II

Date Initiated: October 20, 2017

Date Posted: November 22, 2017

Recall Number: Z-0103-2018

Event ID: 78307

Reason for Recall:

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.

Status: Terminated

Product Quantity: 30 units

Code Information:

Lot 04A9938

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated