INTROCAN SAFETY 3 recallZ-1397-2025 · B Braun Medical Inc · initiated Feb 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Increased risk for valve housing detachment causing leakage.
FDA root cause category: Process control
What the company is doing
An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 2/13/25 was mailed to consignees notifying them of this product removal. Consignees are instructed to review the recall notification and to forward the notice along to those in their organization and to those to which product was further distributed. Consignees are to quarantine any affected devices in their inventory and coordinate product return by completion and return of the provided Product Recall Acknowledgement Form. Consignees with any questions are to contact B Braun at 844-903-6417.
Recall details
- Recall number
- Z-1397-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 17, 2025
- Posted by the FDA
- Mar 19, 2025
- Recalling firm
- B Braun Medical Inc
- Quantity
- 28,200 units
- Product code
- FOZ
- FDA submissions
- K182870, K213085, K111236
- Distribution
- Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
Product description
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Code information (models, lots, serial numbers)
Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INTROCAN SAFETY® 3 4251128-02B. Braun Medical Inc. · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall19 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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