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
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.
CaliforniaFloridaGeorgiaIllinoisIndianaMarylandMinnesotaMissouriNorth CarolinaNew MexicoNew YorkPennsylvaniaTennesseeTexasVirginiaWashington
Questions about this recall
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 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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