Recall Z-1882-2015 ยท NYU Catheter, Hemodialysis, Implanted, Coated
Covidien LLC
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
| Date | Jul 1, 2015 (initiated Apr 23, 2015) |
| Status | Terminated |
| Reason | Catheters may not meet antimicrobial specification |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic (Covidien) issued recalll letter dated April 24, 2015, via FedEx overnight delivery to all affected customers. Customers were requested to quarantine and discontinue use of the affected devices. Customers were instructed to complete A Recalled Product Return Form for product returns. Customer Service will respond with a Return Goods Authorization (RGA) number and shipping documents Customers with questions were instructed to contact their Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am 6:30pm ET, at (800)-882-5878. For questions regarding this |
| Quantity | 72,363 US - 24,631 Internationally |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Nether |
| FDA record | Open on fda.gov |