CLASS II ONGOING Device recall · Reported 4 Oct 2023 · FDA Enforcement Report

Palindrome Chronic Catheter Kit Symmetrical Tip14./Ch recalled

Covidien is recalling Palindrome Chronic Catheter Kit Symmetrical Tip14./Ch, distributed nationwide in the US. The recall was initiated on 22 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272

Quantity recalled3050 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2632-2023
FDA event ID: 92902
Recalling firm: Covidien, Mansfield, MA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Aug 2023
FDA classified: 25 Sep 2023
Reported: 4 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

22 Aug 2023	Recall initiated by company
25 Sep 2023	Classified by FDA	+34 days
4 Oct 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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