Hemodialysis tubing connector may not fully insert, risking flow occlusion
B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing because the patient connector may fail to fully insert into the Locksite, potentially causing blood flow obstruction during dialysis treatment.
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 with potential for flow occlusion during critical hemodialysis procedures. While no injuries have been reported, the defect affects a life-sustaining medical device where incomplete connector insertion poses risk of therapy disruption.
Plain-English summary
B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing (Model SL-2000M2095W, UDI-DI 04046955348800, all unexpired lots) used to transfer blood between patients and hemodialyzers during dialysis treatment. Approximately 142,336 units have been distributed nationwide in the United States.
The patient connector may not fully insert into the Locksite. When the connector is not completely inserted, the internal septum may not open fully enough to prevent restrictions to blood flow. This incomplete insertion could result in occlusion or restricted flow during dialysis procedures.
When incomplete insertion occurs, the obstruction may cause therapy delays and force clinicians to switch from the prograde rinseback method to retrograde flow methods. Healthcare providers using this product should contact B. Braun Medical Inc. for guidance on the recall and appropriate corrective actions.
The recalled product
- Product
- STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
- Manufacturer
- B Braun Medical Inc
- Affected units
- 142,336
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 (2)
- UDI-DI 04046955348800
- All Unexpired Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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