FDA Medical Device Recalls (openFDA)
Covidien LP: Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
- Recall number
- Z-2632-2023
- Recalling firm
- Covidien LP
- Product
- Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
- Status
- Open, Classified
- Initiated
- 2023-08-22
- Posted
- 2023-09-25
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- UDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272
- 510(k) numbers
- ["K111372"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28