INTROCAN SAFETY recallZ-0009-2023 · B Braun Medical Inc · initiated Sep 1, 2022
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
Potential for leakage at the catheter hub.
FDA root cause category: Process control
What the company is doing
On September 1, 2022, the firm notified customers of the recall via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine recalled product. Customers should return completed response forms to B. Braun Medical Inc. Once the form is received, B. Braun Customer Support will contact customers with instructions on returning any impacted product and provide credit and/or replacement of the product based on the individual customer's needs.
Recall details
- Recall number
- Z-0009-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 1, 2022
- Posted by the FDA
- Oct 6, 2022
- Recalling firm
- B Braun Medical Inc
- Quantity
- 94,000 US
- Product code
- FOZ
- FDA submissions
- K020785
- Distribution
- Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
Product description
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INTROCAN SAFETY® 4251890-02B. Braun Medical Inc. · INTRODUCER, CATHETER1 recall2 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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