B Braun Introcan Safety 3 IV Catheter Recall: Valve Housing Detachment Risk
B Braun recalls Introcan Safety 3 IV catheters due to increased risk of valve housing detachment causing leakage. Affected models include 22 gauge, 1 inch, PUR, Winged catheters with specific serial numbers.
Use caution until it’s fixed
Increased risk for valve housing detachment causing leakage.
Contact the company
What happened, in plain English
B Braun is recalling certain Introcan Safety 3 IV catheters because the valve housing might detach, leading to leakage. This could cause infections or other complications during medical procedures. Read more at govinfonow.com/recall/52844-b-braun-introcan-safety-3-iv-catheter-recall-valve-housing.
Source Summary by GovInfoNow · govinfonow.com/recall/52844-b-braun-introcan-safety-3-iv-catheter-recall-valve-housing · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1397-2025
Cite this page
“B Braun Introcan Safety 3 IV Catheter Recall: Valve Housing Detachment Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52844-b-braun-introcan-safety-3-iv-catheter-recall-valve-housing. Based on FDA recall #Z-1397-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1397-2025%22&limit=1).
Why it’s dangerous
The valve housing in these IV catheters can detach during use, causing leakage of the IV solution. This leakage may lead to infections or other complications if not properly managed.
Who’s affected
Healthcare professionals and patients using the recalled IV catheters are affected. Those with the specific model numbers and serial numbers listed in the recall are most at risk.
How to tell if you have this one
Check for the model number 4251128-02 on the catheter packaging. The UDI-DI number 04046964014017 and lot number 24F09G8952 are also associated with this recall.
- Brand
B Braun- Category
Medical device
What to do — step by step
Check Product Details
Review the model number, UDI-DI, and lot number on the catheter packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 16 states, and outside the U.S.
FDA distribution: “Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Illinois, Indiana, Maryland, Minnesota, Missouri, New Mexico, New York, North Carolina, Pennsylvania, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1397-2025 (February 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1397-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.