BD DTX Plus, Custom single-line pressure monitoting kit.
FDA device recall Z-1563-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Becton Dickinson Medical Systems
- Reason for recall
- Actuating tab may detach from the stopcock body, allowing fluid leak.
- Action taken
- Consignees were notified by phone and fax on 07/01/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 85 units
- Distribution
- Nationwide, including VA facilities in NY, SD, IL, OH and military facilities in GA, NC and Guam. Foreign distribution to Japan.
- Date initiated
- 2005-07-01
- Date posted
- 2005-09-21
- Date terminated
- 2011-08-09
- 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 |
|---|---|---|
| DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES (K935782) | Ohmeda Medical | 1994-08-01 |