BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
FDA device recall Z-0587-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Becton Dickinson Infusion Therapy
- Reason for recall
- Splittable catheter introducer may not fully split or may separate non-uniformly.
- Action taken
- On 02/03/2004, all consignees were notified by telephone and letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 12000 units
- Distribution
- Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
- Date initiated
- 2004-02-03
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-10
- Location
- Sandy, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTROSYTE CATHETER (K974764) | Becton Dickinson Infusion Therapy Systems, Inc. | 1998-02-26 |