FDAClass IIJune 2, 2021

Gambro Cartridge Blood Set recall

Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis…

Why was Gambro Cartridge Blood Set recalled?

There is a potential leak between the venous patient connector and patient's hemodialysis access.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Product Code: 101025; Lot 1000276191, UDI: 37332414007837

Product
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis…
Recalling firm
Baxter Healthcare Corporation
Quantity
17,487 units
Distribution
Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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