Product Wiki · Recalls · U.S. FDA — Device Enforcement

Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an… — recall Z-2382-2024

U.S. FDA — Device Enforcement · United States · 2024-06-17 · Class II

As described by U.S. FDA — Device Enforcement: 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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2382-2024
Date of alert
2024-06-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B. Braun Medical, Inc.
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Barcode (EAN/GTIN)
04046955592715
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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