Agency classClass IIOur severity:High FDA (Devices)·Z-0133-2024·Announced 2023-11-15

Medical administration set for radiation therapy recalled due to leakage risk

B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a product used in critical radiation therapy administration. Although no illnesses or injuries have been reported, the confirmed manufacturing defect presents real risk of serious harm including bloodstream infection, therapy delay, and hazardous material exposure. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling THERASPHERE ADMIN SET, Article No. 7M2650, a sterile, single-use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy. The recall affects 760 units distributed in the United States, Canada, and Singapore, specifically lot 0061790166.

The recall is due to a manufacturing issue that may cause the administration set to leak. Leakage may result in a delay of therapy, an increase in the risk of bloodstream infection, and exposure of both patients and healthcare workers to hazardous medication. The manufacturer has indicated there is potential for life-threatening situations to occur that could require additional medical intervention.

The recalled product

Product: THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Radiation therapy administration set
Hazard: leakage
bloodstream-infection
medication-exposure
therapy-delay
Affected units: 760

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)

UDI-DI: 5060116920635 Lot 0061790166

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by B. Braun Medical, 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 9 products in this recall →

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