FDA recall Z-1397-2025

B Braun Medical Inc · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2025-02-17
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1397-2025