Pentalumen TD Thermodilution Catheter, Sterile
FDA device recall Z-0305-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- Thermodilution catheters have a potential for ruptured lumens within the catheter.
- Action taken
- Consignees were notified by letter on 11/19/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYG
- Quantity affected
- 495 units
- Distribution
- AR,AZ, CA, FL, LA, MA, NC, OR, PA, TN, TX, UT, VA, WA. VA facilities in AR,AZ,FL and NC. No military or foreign distribution.
- Date initiated
- 2003-11-19
- Date posted
- 2004-07-20
- Date terminated
- 2004-04-14
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOW-DIRECTED HEPARIN COATED THERMODIL (K832957) | Sorensen Research | 1983-09-29 |
| FLOW-DIRECTED THERMODILUTION CATHETER (K812800) | Sorensen Research | 1981-10-20 |