Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
FDA Recall Z-0009-2023 · Posted 2022-10-06
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Recalling FirmB Braun Medical Inc
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2022-09-01
Product Quantity94,000 US
Reason for Recall
Potential for leakage at the catheter hub.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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