Infusomat SPACE PUMP IV SET recall
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog…
Why was Infusomat SPACE PUMP IV SET 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 04046955324804; All Lots Distributed After 06SEP2023.
- Product
- Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog…
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 1872 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- July 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)