CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
Infusomat UNIV recalled by B. Braun Medical
B. Braun Medical is recalling Infusomat UNIV, distributed nationwide in the US. The recall was initiated on 17 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2392-2024
- FDA event ID
- 94823
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2024
- FDA classified
- 17 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 17 Jun 2024 | Recall initiated by company | |
| 17 Jul 2024 | Classified by FDA | +30 days |
| 24 Jul 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Is Infusomat UNIV recalled?
Yes. B. Braun Medical recalled Infusomat UNIV on 17 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2392-2024.
Why was it 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 lots are affected?
UDI-DI 04046964294679; All Lots Distributed After 01AUG2023.
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
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| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |