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.
What this means for you
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
- Hazard
- occlusion
- incomplete-insertion
- flow-restriction
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.
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