PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/C
FDA device recall Z-0411-2009 · posted 2008-12-04 · Terminated
Recall details
- Recalling firm
- Covidien
- Reason for recall
- Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Action taken
- Starting on 9/19/08, Covidien Sales Representatives visited each of the hospitals that received the catheters, informed the staff that the Venetrac insertion stylets were too short, and placed pink corrective sticker labels on any unused product. Should you require additional information, please contact jim.welsh@covidien.com or 508-216-8532.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- NYU
- Quantity affected
- 20 units
- Distribution
- Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA.
- Date initiated
- 2008-09-19
- Date posted
- 2008-12-04
- Date terminated
- 2008-12-04
- Location
- Argyle, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING (K060509) | Tyco Healthcare Group | 2006-06-23 |
| 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY (K051584) | Kendall | 2005-10-06 |