Class 2 Device Recall Palindrome RT Chronic Catheter Kit Symmetrical Tip

• Date Initiated by Firm: May 28, 2021
• Create Date: August 27, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2372-2021
• Recall Event ID: 88250
• 510(K)Number: K123196
• Product Classification: Catheter, hemodialysis, implanted - Product Code MSD
• Product: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
• Code Information: Lot Numbers: 2034400130 1812200184 1911500092 2000700096 2034400084 1816400076 1914800226 2004400083 1724900107 1818500196 1924000133 2014900152 1731200157 1819100094 1926100267 2019500164 1731900150 1826200149 1926100246 2027200171 1801000137 1903500128 1927300072 2028200206 1802400068 1908800158 1930900080 2034400084 1810400148 1907800094 1930900081 2034400130
• Recalling Firm/ Manufacturer: Covidien, LP; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Catherine Wrenn; 203-492-5000
• Manufacturer 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).
• FDA Determined Cause: Labeling design
• Action: 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
• Distribution: Worldwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MSD and Original Applicant = COVIDIEN