FDA recall Z-0104-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-10-20

Report date

2017-11-22

Termination date

2020-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lakewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2018