Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P

Recall Initiated

May 28, 2021

Recall Number

Z-2371-2021

Firm Location

North Haven, CT

Reason for Recall

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

Distribution

Worldwide distribution.

Lot / Code Info

Lot Numbers: 1724200116 1815000199 1921300032 1932300191 1725600107 1815800076 1921300034 1932300192 1727100076 1817100090 1927500067 2023300141 1728600062 1817700206 1929400086 2027200174 1734700104 1826800141 1929500067 2026000073 1801000128 1831600197 1929500068 2028200214 1802400119 1833100112 1929500071 2028200215 1804000126 1905600140 1929500088 2033100065 1805200078 1906000165 1929500089 2032800041 1806600074 1908400286 1929500072 2034400102 1807300167 1906700185 1930900073 1808600066 1920500223 1930900074

Root Cause

Labeling design

Action Taken

A Medical Device Market Withdrawal notification letter dated 5/28/21 was sent to customers. Actions being taken by Medtronic 1. Medtronic is developing point-of-use labeling reinforcing the important user assembly steps contained within the IFU related to the hub/back end assembly procedure. 2. The IFU for Palindrome" RT and Palindrome" Precision RT chronic hemodialysis catheters will be updated to enhance the detailed instructions for users related to the steps required for hub/back end assembly. Actions you should take 1. Please immediately quarantine and discontinue use of affected item codes and lots listed in Attachment A. 2. Please return affected product as indicated below. All unused products from the affected item codes and lots must be returned. 3. If you have distributed the Palindrome" RT and Palindrome" Precision RT chronic hemodialysis catheters listed in Attachment A, please promptly forward the information from this letter to those recipients. 4. Complete the Product Return Form even if you do not have inventory. Purchased directly from Medtronic 1. Complete the Product Return Form and fax or email to Medtronic. 2. Ship affected product with RGA number provided by Customer Service to: Medtronic Attn: Field Returns 195 McDermott Road North Haven, CT 06473 USA Fax to 800-895-6140 or email to rs.covidienfeedbackcustomerservice@medtronic.com Credit for returned affected product will be issued based on the RGA number. Exception: Customers with zero inventory, fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com Purchased from a distributor 1. Complete the Product Return Form and fax or email to Medtronic 2. Contact your distributor directly to arrange for return of product back to your distributor. Fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com This action is being taken with the knowledge of the FDA and other regulatory authorities. We request that you contact Medtronic if you experienced a quality problem or adverse event. Ema