Terumo recalls specific bone marrow procedure packs due to incorrect patient label lot numbers, catalog numbers, and expiry dates. The sterile product may not have been properly cleared for sterility, requiring post-market review.
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.
Terumo is recalling bone marrow procedure packs with incorrect patient labels that could affect sterility clearance. This means the product might not be safe for use as intended, though no injuries have been reported.
The patient labels in the procedure packs have incorrect lot numbers, catalog numbers, and expiry dates. Since the product is sterile, this could mean the product wasn't properly cleared for sterility, potentially leading to infection risks.
Patients undergoing bone marrow procedures who use the specific Terumo Harvest BMAC2-120-01 Bone Marrow Procedure Pack with catalog number 51423 are affected. Medical professionals administering these procedures are most at risk.
Check for the product name 'HARVEST(R) TERUMOBCT, BMAC2-120-01 Bone Marrow Procedure Pack' with catalog number 51423. The lot number on the box label should be correct, but the patient labels have incorrect details.
Verify the patient labels for correct lot number, catalog number, and expiry date on the procedure pack.
The recall indicates potential issues with sterility clearance, but no injuries have been reported. Terumo is conducting post-market reviews to assess safety.
Look for the product name 'HARVEST(R) TERUMOBCT, BMAC2-120-01 Bone Marrow Procedure Pack' with catalog number 51423.
The recall does not specify a remedy, so check the labels for correctness and contact Terumo for further guidance.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-0104-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-0104-2018 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
