FDA Medical devices recall ·
Introcan Safety 3 Closed IV Catheter 22 Ga recall
- Recall number
- Z-1397-2025
- Date
- (initiated February 17, 2025)
- Company / brand
- B Braun Medical Inc
824 12th Ave, Bethlehem, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 28,200 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Why was it recalled?
Increased risk for valve housing detachment causing leakage.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Florida Georgia Illinois Indiana Maryland Minnesota Missouri North Carolina New Mexico New York Pennsylvania Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1397-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.