Recall Z-0411-2009 ยท NYU Catheter, Hemodialysis, Implanted, Coated
Covidien
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional c
| Date | Dec 4, 2008 (initiated Sep 19, 2008) |
| Status | Terminated |
| Reason | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 20 units |
| Distribution | Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA. |
| FDA record | Open on fda.gov |