FDAClass IIJuly 24, 2024

Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used recall

Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication…

Why was Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used recalled?

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

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 04046964186127; All Lots Distributed After 01AUG2023.

Product
Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication…
Recalling firm
B. Braun Medical, Inc.
Quantity
5672116 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Recall date
July 24, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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