Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P

Recall Initiated

May 28, 2021

Recall Number

Z-2370-2021

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: 1725600117 1807300169 1904900113 2009300115 1729100070 1810400154 1909400116 2019500282 1731200151 1812900134 1920500220 2021000088 1732600132 1814300200 1926100254 2027200198 1734700110 1817100089 1930900078 2028200205 1800300131 1821300123 1930900075 2034400101 1805900127 1824700118 1930900076

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