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Recall Observatory FDA recall evidence

Device product

Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255

Z-2395-2024

June 17, 2024

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 94823
Status
Ongoing
Classification
Class II
Quantity
1872 units
Official record key
device-enforcement:Z-2395-2024

Official wording

Reason: 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.

Code information: UDI-DI 04046955324804; All Lots Distributed After 06SEP2023.

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.