Terumo BCT Bone Marrow Procedure Pack Recall for Labeling Errors
Terumo BCT is recalling specific bone marrow procedure packs because patient labels contain incorrect lot numbers, catalog numbers, and expiry dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves labeling errors and questions regarding sterility clearance, which aligns with the rubric for moderate severity involving minor labeling errors or precautionary measures.
Plain-English summary
Terumo BCT, Inc. is recalling the HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack (REF 51416). The recall involves 30 units from Lot 04A9938. The product is intended for private practice and clinical use only and is marked as sterile.
The recall was initiated because the patient labels included in the procedure packs are printed with incorrect lot numbers, catalog numbers, and expiry dates. The lot number on the procedure pack box label is correct. The expiration date noted on the labels was not beyond the initiation date of the recall. Additionally, the clearance of specific K-numbers raises questions about whether the product was cleared with a sterility claim, necessitating further post-market follow-up to assess safety risks.
The affected products were distributed in California, Colorado, Missouri, New York, Pennsylvania, Texas, Virginia, Wisconsin, Turkey, Austria, and Spain. Healthcare providers and patients should stop using the affected procedure packs and contact Terumo BCT for instructions on return or replacement.
The recalled product
- Product
- HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
- Manufacturer
- Terumo BCT, Inc.
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 04A9938
Distribution
Part of a larger recall action
This product is one of 2 recalled by Terumo BCT, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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