Z-2372-2021Class II

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm...

Name: Z-2372-2021 Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm...
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 Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P 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-2372-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-28
Posted: 2021-08-27
Recalling firm: Medtronic, Inc.
Product: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
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: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2372-2021
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

K123196Class IIPalindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter, Palindrome Precision Hsi Chronic CathCovidien / cleared 2013-01-31

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)