HARVEST — Class II medical device recall Z-0104-2018

Terminated recall by Terumo BCT, Inc., reported 2017-11-22, distributed in CA, MO, NY, PA, TX, VA, WI. The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed w

Recall number	`Z-0104-2018`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Terumo BCT, Inc., Lakewood, CO, United States
Recall initiated	2017-10-20
Classified	2017-11-16
Reported by FDA	2017-11-22
Terminated	2020-08-21
Distributed	CA, MO, NY, PA, TX, VA, WI
Countries outside the US	AT, ES, TR
Quantity	281 units
Reason classes	labeling, sterility
UPC / GTIN / UDI-DI	`05020583514232`, `35020583514233`
Lot numbers	`04A9939`
Model numbers	`51423`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0104-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.