Z-1397-2025 Class II Ongoing
FDA device recall Z-1397-2025 was initiated by B Braun Medical Inc on February 17, 2025 and is designated Class II. Reason for recall: Increased risk for valve housing detachment causing leakage. The recall status is ongoing. Affected quantity: 28,200 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,200 units
Product Description
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Reason for Recall
Increased risk for valve housing detachment causing leakage.
Distribution Pattern
Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
Code Information
Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.