CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report

Introcan Safety 3 Closed IV Catheter.., PUR, Winged recalled

B Braun Medical is recalling Introcan Safety 3 Closed IV Catheter.., PUR, Winged, distributed in 16 states. The recall was initiated on 17 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.

Quantity recalled28,200 units

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-1397-2025
FDA event ID: 96293
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class II
Status: Ongoing
Recall initiated: 17 Feb 2025
FDA classified: 19 Mar 2025
Reported: 26 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

17 Feb 2025	Recall initiated by company
19 Mar 2025	Classified by FDA	+30 days
26 Mar 2025	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

Increased risk for valve housing detachment causing leakage.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

Where it was distributed

Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.

California Florida Georgia Illinois Indiana Maryland Minnesota Missouri North Carolina New Mexico New York Pennsylvania Tennessee Texas Virginia Washington

Questions about this recall

Is Introcan Safety 3 Closed IV Catheter.., PUR, Winged recalled?

Yes. B Braun Medical recalled Introcan Safety 3 Closed IV Catheter.., PUR, Winged on 17 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1397-2025.

Why was it recalled?

Increased risk for valve housing detachment causing leakage.

Which lots are affected?

Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.

Where was it sold?

Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: 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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