Product Safety Recalls

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B. Braun Medical, Inc. Recall 94823

Description: Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424

B. Braun Medical, Inc. Recall 94823 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2391-2024
Event ID94823
Event DescriptionInfusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Quantity32752 units
Recall ReasonPotential 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.
Device Classification20240724
Device Code InfoUDI-DI 04046964837906; All Lots Distributed After 01AUG2023.
Center Classification Date20240717
Recall Initiation Date20240617
Recalling FirmB. Braun Medical, Inc.
Initial Notification Letter
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