Hemodialysis bloodline connector insertion defect may cause flow restriction
B Braun Medical is recalling hemodialysis bloodline tubing because the patient connector may not fully insert into the device, potentially blocking blood flow and delaying treatment. Affected units were distributed nationwide.
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: FDA Class II recall involving potential flow occlusion in a critical medical device with no reported injuries. Hazard is theoretical—source does not report illnesses or injuries—which per rubric limits score to at most 3.
Plain-English summary
B Braun Medical Inc is recalling the STREAMLINE BLOODLINE LONG VERSION hemodialysis blood transfer tubing (Model SL-2000M2095L), which is used to transfer blood between a patient and hemodialyzer. A total of 2,021,376 units were distributed nationwide.
The patient connector on these bloodline tubes may not fully insert into the Locksite connection point. When incompletely inserted, the internal septum may not open fully, potentially restricting blood flow.
Flow restrictions during prograde rinseback procedures could delay hemodialysis treatment or require clinicians to switch to retrograde flow methods. This recall was classified by the FDA as a Class II recall.
The recalled product
- Product
- STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L
- Manufacturer
- B Braun Medical Inc
- Affected units
- 2,021,376
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 04046955348909
- 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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