Device product
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Z-1397-2025
Product summary
- Event
- Event 96293
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28,200 units
- Official record key
device-enforcement:Z-1397-2025
Official wording
Reason: Increased risk for valve housing detachment causing leakage.
Code information: Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.
Distribution pattern: Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
Derived failure modes
-
Unknown
Increased risk for valve housing detachment causing leakage.