Recall Z-1873-2015 ยท MSD Catheter, Hemodialysis, Implanted
Covidien LLC
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
| 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 |
510(k) clearances named in this recall
| K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) Kendall, Aug 4, 2006 |
| K112477 | PALINDROME H, SI, HSI CHRONIC CATHETER Covidien, Sep 28, 2011 |
| K123196 | PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH Covidien, Jan 31, 2013 |