FDAClass IINovember 15, 2023

Ft1000s Fluid Transfer SET recall

FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.

Why was Ft1000s Fluid Transfer SET recalled?

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

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: 4022495769558 Lots 0061755752, 0061761812, 0061766279

Product
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
Recalling firm
B. Braun Medical, Inc.
Quantity
24,400 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Recall date
November 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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