CLASS II ONGOING Device recall · Reported 8 Sep 2021 · FDA Enforcement Report

Palindrome RT Repair Kit TAL, Sterile recalled by Covidien

Covidien is recalling Palindrome RT Repair Kit TAL, Sterile. The recall was initiated on 28 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 1616800188 1719300113 1828900138 2023300147 1703200130 1816400079 1833800127 2026000048 1713700156 1822000123 2009300120

Quantity recalledN/A

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-2365-2021
FDA event ID: 88250
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 28 May 2021
FDA classified: 27 Aug 2021
Reported: 8 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 May 2021	Recall initiated by company
27 Aug 2021	Classified by FDA	+91 days
8 Sep 2021	Published in enforcement report	+12 days

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

Reason for recall

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

Product as listed by the FDA

Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

Which lots are affected?

Lot Numbers: 1616800188 1719300113 1828900138 2023300147 1703200130 1816400079 1833800127 2026000048 1713700156 1822000123 2009300120

Where was it sold?

Worldwide distribution.

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.

Other products in this recall event

17 other products · FDA event 88250

This product is part of a recall event; the main page for the event is Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled.

Reported	Class	Recall	Company	Reason	Where
8 Sep 2021	CLASS II	Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Repair Kit TAL, Sterile recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Chronic Catheter Kit Symmetrical Tip recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Repair Kit TAL, Sterile recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Chronic Catheter Kit Symmetrical Tip recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Repair Kit TAL, Sterile recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Chronic Catheter Kit Symmetrical Tip recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Chronic Catheter Kit Symmetrical Tip recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Repair Kit TAL, Sterile recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Chronic Catheter Kit Symmetrical Tip recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Chronic Catheter Kit Symmetrical Tip recalled by Covidien	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome Precision RT Chronic Catheter Kit Symmetrical recalled	Covidien	Other	CT
8 Sep 2021	CLASS II	Palindrome RT Repair Kit TAL, Sterile recalled by Covidien	Covidien	Other	CT

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