Recall Z-0009-2023 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
B Braun Medical Inc
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
| Date | Oct 6, 2022 (initiated Sep 1, 2022) |
| Status | Open, Classified |
| Reason | Potential for leakage at the catheter hub. |
| Root cause | Process control |
| 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. |
| Quantity | 94,000 US |
| Distribution | Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020785 | INTROCAN SAFETY IV CATHETER B.Braun Medical, Inc., Aug 28, 2002 |