Hemodialysis Bloodline Tubing Recall Over Incomplete Connector Insertion Risk
B Braun is recalling SL BLOODLINE FOR FMC 2008 SERIES hemodialysis tubing nationwide due to incomplete connector insertion that may cause blood flow restrictions during 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 recall involving a critical hemodialysis device with a design defect that poses risk of blood flow obstruction and treatment delays, but no reported illnesses or injuries are documented in the source. The score reflects theoretical risk to patients requiring lifesaving dialysis treatment.
Plain-English summary
B Braun Medical Inc is recalling 10,658,351 units of SL BLOODLINE FOR FMC 2008 SERIES tubing (Model/Catalog Number: SL-2000M2095) used to transfer blood between patients and hemodialysers during hemodialysis treatment.
The tubing has been distributed nationwide in the United States. The recall is due to a design defect where incomplete insertion of the patient connector into the Locksite may prevent the internal septum from opening fully, potentially causing blood flow restrictions and occlusion during prograde rinseback procedures. When this occurs, therapy may be delayed and clinicians may need to switch to retrograde flow methods instead.
The recalled product
- Product
- SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
- Manufacturer
- B Braun Medical Inc
- Affected units
- 10,658,351
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 04046964367762
- 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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