Z-2368-2021Class II

Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144

Name: Z-2368-2021 Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Creator: Covidien, LP
Published: 2021-05-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-05-28 / Open, Classified / root cause: labeling and UDI

FDA source

Covidien, LP began a recall of Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 on 2021-05-28. FDA classified it as Class II and gives the reason as "This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2368-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-28
Posted: 2021-08-27
Recalling firm: Medtronic, Inc.
Product: Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Product code: MSD Catheter, Hemodialysis, Implanted
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).
Root cause tag: labeling and UDI
FDA root 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 [email protected] 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 [email protected] 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 [email protected] 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.
Product codes and lots: Lot Numbers: 1704700210 1822600138 1826200177

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2368-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2358-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2359-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2360-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2361-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2362-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2363-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2364-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2365-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2366-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2367-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2368-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2369-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2370-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2371-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2372-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2373-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2374-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27
Z-2375-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-08-27

Product code MSD

K111817Class IIPalindrome Rt Chronic CatheterCovidien / cleared 2011-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)