Recall archive / FDA device enforcement
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter. — FDA record Z-1397-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
- Reason
- Increased risk for valve housing detachment causing leakage.
- Classification
- Class II
- Recalling firm
- B Braun Medical Inc
- Quantity
- 28,200 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1397-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 26, 2025
- Recall initiation date
- Feb 17, 2025
- Center classification date
- Mar 19, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.