Z-2632-2023Class II

Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm

Name: Z-2632-2023 Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Creator: Covidien LP
Published: 2023-08-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-08-22 / Open, Classified / root cause: labeling and UDI

FDA source

Covidien LP began a recall of Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm on 2023-08-22. FDA classified it as Class II and gives the reason as "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". 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-2632-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-22
Posted: 2023-09-25
Recalling firm: Medtronic, Inc.
Product: Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Product code: MSD Catheter, Hemodialysis, Implanted
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.
Root cause tag: labeling and UDI
FDA root 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: [email protected] 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.
Product codes and lots: UDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2632-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2632-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-25

Product code MSD

K111372Class IITal Pallindrome (Tm) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (Tm) Dual Lumen Catheter, Palindrome (Tm)...Covidien / cleared 2011-08-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)