Hemodialysis bloodline sets recalled over micro air bubbles from damaged connectors
B. Braun is recalling Streamline Bloodline Sets for Dialog because damaged arterial and venous patient connectors may cause micro-air bubbles in the bloodline and air-in-line alarms.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Streamline Bloodline Sets for Dialog, model SL-2010M2096, used as hemodialysis bloodlines, are being recalled.
There is potential for micro-air bubbles to be observed in the bloodline, and for air-in-line alarms, due to damaged arterial and venous patient connectors.
The enforcement record lists 1,298,454 units, with an expansion figure of 1,589,674 dated 3/5/26. The affected sets carry UDI-DI 04046964367786 across lots including A2500119, A2500121, A2500128, A2500129 and A2500130. The product was distributed nationwide in the United States. The FDA has classified the recall as Class I.
Dialysis units should identify affected lots, quarantine them and follow B. Braun's instructions.
The recalled product
- Product
- Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
- Manufacturer
- B BRAUN MEDICAL INC
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 (20)
- Model No. SL-2010M2096
- UDI-DI 04046964367786
- Lot Numbers: A2500119
- A2500121
- A2500128
- A2500129
- A2500130
- A2500132
- A2500133
- A2500134
- A2500149
- A2500150
- A2500151
- A2500180
- A2500181
- A2500182
- A2500185
- A2500198
- A2500199
- A2500200
Distribution
Distributed nationwide across the United States.
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