Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HARVEST(R) TERUMOBCT Recalled by Terumo BCT, Inc. Due to The patient labels included in the BMAC system...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo BCT, Inc. directly.
Affected Products
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Quantity: 281 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 7 states: CA, MO, NY, PA, TX, VA, WI
About Terumo BCT, Inc.
Terumo BCT, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report