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Hemodialysis Bloodlines recallZ-3174-2024 · B Braun Medical Inc · initiated Aug 15, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method

FDA root cause category: Device Design

What the company is doing

B. Braun issued Urgent Medical Device Correction letter on 8/15/24 via USPS. Letter states reason for recall, health risk and action to take: Interim Measures for User: It is recommended that users follow the additional instructions provided in Attachment 01 for connecting the patient connector to the Locksite during prograde rinseback procedures. This attachment should be posted in clinical areas where Streamline Airless System Hemodialysis Bloodlines are utilized and where they are stored until further notice. Actions Required by 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. b. If you are a distributor that distributes partial cases, please ensure a copy of this notice is forwarded to your consignees. 2. Determine your current inventory. Review your inventory frequently to check these product codes and lot numbers. Post this notification where the affected products are stored. 3. 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 [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). Adverse reactions or quality problems experienced with this product, or questions about this correction may be reported to BBMl's Postmarket Surveillance Department by calling 1-833-425-1464.

Recall details

Recall number
Z-3174-2024
Status
Open, Classified
Initiated by the company
Aug 15, 2024
Posted by the FDA
Sep 19, 2024
Recalling firm
B Braun Medical Inc
Quantity
4671540 units
Product code
FJK
FDA submissions
K080807
Distribution
US Nationwide distribution.

Product description

STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D

Code information (models, lots, serial numbers)

UDI-DI 04046955348763; All Unexpired Lot Numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95171).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page