CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
Celsite Babyport Set Pur 4,5f Iv Usa recalled by B.Braun Medical S.A.S
B.Braun Medical S.A.S is recalling Celsite Babyport Set Pur 4,5f Iv Usa, distributed nationwide in the US. The recall was initiated on 21 Jul 2025 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-2528-2025
- FDA event ID
- 97407
- Recalling firm
- B.Braun Medical S.A.S, Chasseneuil du Poitou CEDEX, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jul 2025
- FDA classified
- 5 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 21 Jul 2025 | Recall initiated by company | |
| 5 Sep 2025 | Classified by FDA | +46 days |
| 17 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
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
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
Where it was distributed
US Nationwide distribution in the state of PA.
Questions about this recall
Why was it recalled?
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Which lots are affected?
Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
Where was it sold?
US Nationwide distribution in the state of PA.
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 26 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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