PlainRecalls
FDA Devices Moderate Class II Ongoing

Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362420

Reported: July 24, 2024 Initiated: June 17, 2024 #Z-2382-2024

Product Description

Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362420

Reason for Recall

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
431999 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362420. Recalled by B. Braun Medical, Inc.. Units affected: 431999 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2382-2024.