Class 2 Device Recall Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet

• Date Initiated by Firm: April 23, 2015
• Date Posted: July 01, 2015
• Recall Status: Terminated on July 26, 2017
• Recall Number: Z-1862-2015
• Recall Event ID: 70985
• 510(K)Number: K060972 K112477
• Product Classification: Catheter, hemodialysis, implanted, coated - Product Code NYU
• Product: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
• Code Information: Item codes identified with an expiry date of February 2018 and earlier
• Recalling Firm/ Manufacturer: Covidien LLC; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: 203-492-5000
• Manufacturer Reason for Recall: Catheters may not meet antimicrobial specification
• FDA Determined 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 recall call 203-492-5000.
• Quantity in Commerce: 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, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NYU; 510(K)s with Product Code = NYU