—#195981

Product

Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K020785
Affected lot / code info: 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

Why it was recalled

Potential for leakage at the catheter hub.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: B Braun Medical Inc
Address: 200 Boulder Dr, Breinigsville, Pennsylvania 18031-1532

Distribution

Distribution pattern: Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada

Timeline

Recall initiated: 2022-09-01
Posted by FDA: 2022-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.