Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arteria
FDA device recall Z-0009-2023 · posted 2022-10-06 · Open, Classified
Recall details
- Recalling firm
- B Braun Medical Inc
- Reason for recall
- Potential for leakage at the catheter hub.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FOZ
- Quantity affected
- 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
- Date initiated
- 2022-09-01
- Date posted
- 2022-10-06
- Location
- Breinigsville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTROCAN SAFETY IV CATHETER (K020785) | B.Braun Medical, Inc. | 2002-08-28 |