Reported Sep 17, 2025 · Ongoing

Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version:…

B.Braun Medical S.A.S.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B.Braun Medical S.A.S. · Celsa Lg Medical · Chasseneuil du Poitou CEDEX, N/A · N/A

Is this the product you have?

  • Brand NameCELSITE
  • Product Name
    • CELSITE BABYPORT SET PUR 4
    • 5F
  • IV USA Model/Catalog Number5433742
  • Software VersionN/A
  • Product Description
    • CELSITE BABYPORT SET PUR 4
    • 5F
  • IV USA ComponentN/A
Lot codes and dates
  • Model/Catalog Number
    • 5433742
    • Primary-DI 04046963594947
    • Lot 37041185
    • Exp 19MAR2030
Amount recalled
58 units

Where it was sold

  • Nationwide
  • PA

Why it was recalled

The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.