Class 2 Device Recall Palindrome" Chronic Catheter Kit Symmetrical Tip

• Date Initiated by Firm: August 22, 2023
• Date Posted: September 25, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2632-2023
• Recall Event ID: 92902
• 510(K)Number: K111372
• Product Classification: Catheter, hemodialysis, implanted - Product Code MSD
• Product: Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Code Information: UDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272
• Recalling Firm/ Manufacturer: Covidien LP; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Erika Winkels; 763-526-8478
• Manufacturer Reason for Recall: Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers on 8/22/23. Required Actions: 1. Immediately quarantine and discontinue use of all unused affected lots of the Palindrome" 14.5 Fr/Ch (4.8 mm) x 23 cm Chronic Catheter Kits. Please note: This recall does not include Palindrome Precision Catheter Kits. 2. Complete the online Customer Confirmation Form using the QR code located at the top of the first page of this letter or by using the link below. We request your response within 3 business days of receiving this notice. Replying promptly will confirm your receipt of this notification and prevent you from receiving additional notices. Customer Confirmation Link: https://www.novasyte.com/medtronic/fa1355 Note: Please complete the online Customer Confirmation Form even if you DO NOT have affected product. 3. If you have affected product, it must be returned for processing. Upon completion of the Customer Confirmation Form, Customer Service will contact you with an RGA number to return all unused affected Palindrome" 14.5 Fr/Ch (4.8 mm) x 23 cm Chronic Catheter Kits from your inventory to Medtronic. 4. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 5. This notice should be passed on to those who need to be aware within your organization or to any organization including, but not limited to, nephrologists, intensivists, implanting and managing physicians, renal nurses, critical care nurses, or other dialysis staff where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. Medtronic has partnered with Novasyte, an IQVIA company, to assist in this recall. For assistance regarding online response processing or product return for this recall, please contact Novasyte using the information below: " Phone number: (855) 566-3445 " Email: medtronic-fa-1355@iqvia.com We regret any inconvenience this may cause. We a
• Quantity in Commerce: 3050 devices
• Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Thailand, 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 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