FDAClass IISeptember 25, 2024

STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to recall

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

Why was STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI 04046955776023; All Unexpired Lot Numbers

Product
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number…
Recalling firm
B Braun Medical Inc
Quantity
4984920 units
Distribution
US Nationwide distribution.
Recall date
September 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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