B Braun Medical Inc: Device Recall

Recall #Z-1397-2025 · 02/17/2025

Class II: Risk

Recall Details

Recall Number: Z-1397-2025
Classification: Class II
Product Type: Device
Recalling Firm: B Braun Medical Inc
Status: Ongoing
Date Initiated: 02/17/2025
Location: Bethlehem, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,200 units

Reason for Recall

Increased risk for valve housing detachment causing leakage.

Product Description

Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

Distribution Pattern

Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.

Other Recalls by B Braun Medical Inc

Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II: Risk 10/29/2025

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

View all recalls by B Braun Medical Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.