FDA Recall Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
Device Description: Streamline Bloodline Set for Dialog+
- Model: SL-2010M2096
- UDI-DI: 04046964367786; 04046964367779
- Impacted Lots: 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
What to Do
Use non-impacted SL-2010M2096 sets or alternate dialysis equipment and disposables if possible. If alternative equipment is not available and affected product must be used to treat patients, users should take additional actions to mitigate patient harm such as air embolism.
On September 30, B Braun Medical Inc. sent all affected customers a letter recommending the following actions:
- If alternate equipment is not available, customers should:
- 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. See excerpt below.
- Increase visual inspection of the bloodlines during treatment. If air ingress or leakage is observed, re-secure or tighten connection using the product IFU. See excerpt below.
- If re-securement or tightening connections does not resolve the concern, stop the procedure, clamp lines, and reposition the patient, and replace bloodline at earliest clinically feasible time.
- If possible, avoid high flow during treatment if microbubbles are present
- Ensure all users in your organization of this product and other concerned personnel are informed of this voluntary correction.
- If you are a distributor and have further distributed the product, please forward the notice to your consignees. The correction is to be extended to the customer level.
- EXCERPT FROM INSTRUCTIONS FOR USE (IFU) of Streamline Bloodline Set for Dialog+:
- When recirculation is complete and patient’s vascular access devices are prepared, attach arterial patient connector to arterial access device as follows:
- Establish luer connection first before engaging the male locking ring. Holding only the clear back end of the patient connector, firmly push the male luer cone into the female luer socket with no more than a quarter (1/4) turn. This connection must be secure before engaging the locking ring
- Twist on the threaded locking ring of the patient connector until it is finger-tight and secure with the access device’s female port
- When recirculation is complete and patient’s vascular access devices are prepared, attach arterial patient connector to arterial access device as follows: