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U.S. Department of Health and Human Services

Class 1 Device Recall Hemodialysis Bloodlines

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 Class 1 Device Recall Hemodialysis Bloodlinessee related information
Date Initiated by FirmSeptember 30, 2025
Date PostedOctober 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0070-2026
Recall Event ID 97609
510(K)NumberK080807 
Product Classification Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
ProductBrand 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
Code Information 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, A2500203, A2500204, A2500205, A2500206, A2500207, A2500208, A2500209, A2500210, A2500211, A2500212, A2500213, A2500214, A2500215, A2500216, A2500217, A2500218, A2500219, A2500220, A2500246, A2500247, A2500248, A2500249, A2500250, A2500251, A2500257, A2500258, A2500259, A2500260, A2500261, A2500262, A2500267, A2500268, A2500269, A2500273, A2500274, A2500275, A2500276, A2500277, A2500278, A2500295, A2500298, A2500299, A2500300;
Recalling Firm/
Manufacturer		 B BRAUN MEDICAL INC
861 Marcon Blvd
Allentown PA 18109-9577
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer Reason
for Recall		The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
FDA Determined
Cause 2		Process control
ActionOn September 29, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 24, 2025, were sent to customers. Actions to be taken: 1. Ensure full adherence to the product Instructions for Use (IFU). In particular, the instructions for secure connection of patient connectors should be followed to reduce the probability of air ingress or leakage. 2. Increase visual inspection of the bloodlines during treatment. If air ingress or leakage is observed, re-secure or tighten connection using the product IFU. In some instances, the dialysis treatment should be stopped. 3. If re-securement or tightening connections does not resolve the concern, replace bloodline at earliest clinically feasible time. 4. If possible, avoid high flow during treatment if microbubbles are present. B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. Note: Product is not being returned as part of this correction notification. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. 2. Return the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). If you have any questions, contact Director, Corporate Communications at 484-240-8373.
Quantity in Commerce1298454 units
DistributionDomestic: US Nationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FJK
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