B. Braun FT1000S Fluid Transfer Sets may leak, risking infection
B. Braun is recalling FT1000S Fluid Transfer Sets due to a manufacturing defect that may cause leakage. This could delay therapy, increase infection risk, and expose 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 an FDA Class II medical device recall where a manufacturing defect may cause leakage. While no illnesses or injuries have been reported, the hazard creates risk of bloodstream infection, therapy delay, and hazardous medication exposure. The risk is serious but theoretical, meeting the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling the FT1000S Fluid Transfer Set (Model No. 356048) due to a manufacturing defect that may cause the device to leak. The affected device is used for direct transfer of fluids between large volume parenteral solution containers in hospital and clinical settings.
The leakage may result in a delay of therapy, increase the risk of bloodstream infection, and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur that may require additional medical intervention.
This recall affects 24,400 units distributed worldwide, including the United States, Canada, and Singapore. The recalled lot numbers are 0061755752, 0061761812, and 0061766279, with UDI-DI 4022495769558.
The recalled product
- Product
- FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 24,400
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-DI: 4022495769558 Lots 0061755752
- 0061761812
- 0061766279
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.
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