CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet recalled

Covidien is recalling Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet, distributed nationwide in the US. The recall was initiated on 23 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem codes identified with an expiry date of February 2018 and earlier

Quantity recalled72,363 US - 24,631 Internationally

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-1883-2015
FDA event ID: 70985
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 23 Apr 2015
FDA classified: 30 Jun 2015
Reported: 8 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

23 Apr 2015	Recall initiated by company
30 Jun 2015	Classified by FDA	+68 days
8 Jul 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

Catheters may not meet antimicrobial specification

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458

Where it was distributed

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.

Nationwide

Questions about this recall

Is Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet recalled?

Yes. Covidien recalled Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet on 23 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1883-2015.

Why was it recalled?

Catheters may not meet antimicrobial specification

Which lots are affected?

Item codes identified with an expiry date of February 2018 and earlier

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 21 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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