Recall Z-0331-2016 ยท NYU Catheter, Hemodialysis, Implanted, Coated
Covidien LLC
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
| Date | Nov 24, 2015 (initiated Oct 14, 2015) |
| Status | Terminated |
| Reason | Incorrectly packaged with a 90 degree bend at the distal tip |
| Root cause | Packaging process control |
| Action | The firm, Medtronic (Covidien), sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/16/2015 to their customers. The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: feedback.customerservice@Covidien.com/Distributor to (203) 492-7719 or email to: PalCathFCA@Covidien.com. Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878. |
| Quantity | 365 units |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH Covidien, Jan 31, 2013 |