Terumo recalls bone marrow procedure packs with incorrect labels that could affect sterility claims. Affected packs have wrong lot numbers, catalog codes, and expiry dates. Consumers should contact Terumo for details.
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 that have incorrect labels with wrong lot numbers, catalog codes, and expiry dates. This could raise questions about the product's sterility claims and safety.
The labels on the packs have incorrect lot numbers, catalog codes, and expiry dates. This could lead to questions about whether the product was properly sterilized, which is critical for medical safety.
Healthcare providers using the Terumo Harvest Bone Marrow Procedure Packs for clinical procedures are most at risk. Patients receiving these packs may be affected if the labels are incorrect.
Check for the product name 'HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack' with lot number 04A9938. The pack is labeled as sterile and sold only with a prescription.
Reach out to Terumo for specific details about the affected product and next steps.
The recall notes that the product's sterility claims are under question, but the exact safety risk is not clear. Terumo will assess the risk further.
Check for the product name 'HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack' with lot number 04A9938.
Contact Terumo directly for specific instructions on what to do with the product.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-0103-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-0103-2018 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.
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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.
