FDAClass IIFebruary 24, 2021

Gambro Cartridge Single Needle Conversion Kit recall

Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the…

Why was Gambro Cartridge Single Needle Conversion Kit recalled?

complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

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 07332414007881, All lots within expiry

Product
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the…
Recalling firm
Baxter Healthcare Corporation
Quantity
385 devices
Distribution
Worldwide distribution.
Recall date
February 24, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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