Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0104-2018·Announced 2017-11-22

Terumo BCT Recalls Bone Marrow Procedure Packs Due to Labeling Errors

Terumo BCT is recalling 281 bone marrow procedure packs because the patient labels contain incorrect lot numbers, catalog numbers, and expiration dates.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, but the source text describes a labeling error and a question about sterility clearance without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or precautionary measures.

Plain-English summary

Terumo BCT, Inc. is recalling 281 units of the HARVEST(R) TERUMOBCT Bone Marrow Procedure Pack (REF 51423). The recall involves patient labels included in the procedure packs that were printed with incorrect lot numbers, catalog numbers, and expiration dates. The lot number printed on the procedure pack box label is correct.

The recall was initiated because the incorrect labeling raises questions about whether the product was properly cleared with a sterility claim, as the product is noted as sterile. The expiration date noted on the labels was not beyond the initiation date of the recall. Further post-market follow-up is required to assess the safety risk of the product.

The affected units were distributed in California, Colorado, Missouri, New York, Pennsylvania, Texas, Virginia, Wisconsin, Turkey, Austria, and Spain. Consumers and healthcare providers should stop using the affected procedure packs and contact Terumo BCT, Inc. for instructions on how to return the product.

The recalled product

Product: HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
Manufacturer: Terumo BCT, Inc.
Category: Medical Device — Bone Marrow Procedure Pack
Hazard: mis-labeling
sterility-uncertainty
Affected units: 281

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 (3)

UDI Case: 35020583514233
51423 Each: 05020583514232
Lot 04A9939

Distribution

Distributed in 8 states:

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 →

Same manufacturer · Terumo BCT, Inc.

See all →

Moderate
Terumo BCT Bone Marrow Procedure Pack Recall for Labeling Errors
FDA (Devices) · 2017-11-22
High
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FDA (Devices) · 2017-11-15
Moderate
Terumo BCT Recalls Adiprep Adipose Transfer System Due to Labeling Error
FDA (Devices) · 2016-12-07

Same hazard · mis labeling