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Palindrome recallZ-2632-2023 · Covidien LP · initiated Aug 22, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2632-2023
Status
Open, Classified
Initiated by the company
Aug 22, 2023
Posted by the FDA
Sep 25, 2023
Recalling firm
Covidien LP
Quantity
3050 devices
Product code
MSD
FDA submissions
K111372
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 description

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

Code information (models, lots, serial numbers)

UDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

42 devices cleared under K111372 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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