FDA Enforcement
Class II
Ongoing
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Recall: Z-1397-2025
·
Reported March 26, 2025
Enforcement
- Recall Number
- Z-1397-2025
- Event ID
- 96293
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B Braun Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 26, 2025
- Initiation Date
- February 17, 2025
- Classification Date
- March 19, 2025
- Address
- 824 12th Ave, N/A, Bethlehem, PA, 18018-3524, United States
Description
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.
Code Info
Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.
Distribution
Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
Quantity
28,200 units