CLASS II Device recall · Reported 2 Dec 2015 · FDA Enforcement Report

Palindrome" Chronic Catheter Kit Symmetrical Tip recalled by Covidien

Covidien is recalling Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14./Ch, distributed nationwide in the US. The recall was initiated on 14 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 1503500094, 1431900098, 1435800009

Quantity recalled280 units

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-0329-2016
FDA event ID: 72416
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 14 Oct 2015
FDA classified: 24 Nov 2015
Reported: 2 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

14 Oct 2015	Recall initiated by company
24 Nov 2015	Classified by FDA	+41 days
2 Dec 2015	Published in enforcement report	+8 days

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

Reason for recall

Incorrectly packaged with a 90 degree bend at the distal tip

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.

Where it was distributed

Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Incorrectly packaged with a 90 degree bend at the distal tip

Which lots are affected?

Lot Numbers: 1503500094, 1431900098, 1435800009

Where was it sold?

Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.

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

4 other products · FDA event 72416

This product is part of a recall event; the main page for the event is Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14./Ch recalled.

Reported	Class	Recall	Company	Reason	Where
2 Dec 2015	CLASS II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14./Ch recalled	Covidien	Packaging Defects	Nationwide
2 Dec 2015	CLASS II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip recalled	Covidien	Packaging Defects	Nationwide
2 Dec 2015	CLASS II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip recalled	Covidien	Packaging Defects	Nationwide
2 Dec 2015	CLASS II	Palindrome Precision Chronic Catheter Kit Symmetrical Tip recalled	Covidien	Packaging Defects	Nationwide

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