Covidien LP: Palindrome Chronic Catheter Kits Recalled for Incorrect Catheter Length

Agency Publication Date: September 25, 2023

Summary

Covidien LP is recalling 3,050 Palindrome Chronic Catheter Kits because some kits labeled as having a 23 cm implant length actually contain a longer 28 cm catheter. Using a catheter of the wrong length can lead to improper placement within a patient's vascular system. Healthcare providers can identify the correct length by checking the labeling printed directly on the catheter body, which should match the intended procedure.

Risk

If a 28 cm catheter is used when a 23 cm length was intended, the tip may be positioned incorrectly in the heart or blood vessels, potentially leading to reduced effectiveness of the treatment or other medical complications.

What You Should Do

Check your inventory for Palindrome Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch(4.8mm)x23cm with Recall Number Z-2632-2023.
Verify if your kits match any of the following Lot Numbers: 2221700131, 2224200233, 2230400271, or 2230400272.
Confirm the device identification using UDI-DI numbers 10884521013162 or 20884521013169 found on the packaging.
Inspect the catheter body itself before use; the actual catheter implant length is correctly labeled on the catheter body even if the outer kit packaging is incorrect.
Contact your healthcare provider or Covidien LP at 15 Hampshire St, Mansfield, Massachusetts for further instructions regarding the use or return of these kits.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Manufacturer notification and identification guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Palindrome Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch(4.8mm)x23cm

Model / REF:

Z-2632-2023

UPC Codes:

10884521013162

20884521013169

Lot Numbers:

2221700131

2224200233

2230400271

2230400272

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92902

Status: Active

Manufacturer: Covidien LP

Sold By: Medical distributors

Manufactured In: United States

Units Affected: 3050 devices

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your inventory for Palindrome Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch(4.8mm)x23cm with Recall Number Z-2632-2023.

Verify if your kits match any of the following Lot Numbers: 2221700131, 2224200233, 2230400271, or 2230400272.

Confirm the device identification using UDI-DI numbers 10884521013162 or 20884521013169 found on the packaging.

Inspect the catheter body itself before use; the actual catheter implant length is correctly labeled on the catheter body even if the outer kit packaging is incorrect.

Contact your healthcare provider or Covidien LP at 15 Hampshire St, Mansfield, Massachusetts for further instructions regarding the use or return of these kits.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).