CLASS II ONGOING Device recall · Reported 3 Jun 2020 · FDA Enforcement Report

Kangaroo Epump Safety Screw Spike with Flush recalled by Cardinal Health

Cardinal Health is recalling Kangaroo Epump Safety Screw Spike with Flush, Anti-free Flow. The recall was initiated on 26 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll

Quantity recalled114,731, 290 total 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-2103-2020
FDA event ID: 84656
Recalling firm: Cardinal Health, Dublin, OH
Classification: Class II
Status: Ongoing
Recall initiated: 26 Dec 2019
FDA classified: 22 May 2020
Reported: 3 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

26 Dec 2019	Recall initiated by company
22 May 2020	Classified by FDA	+148 days
3 Jun 2020	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

The feeding spike sets may leak at the interface of the tube and spike connector.

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

Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

The feeding spike sets may leak at the interface of the tube and spike connector.

Which lots are affected?

All

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

5 other products · FDA event 84656

This product is part of a recall event; the main page for the event is Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product recalled.

Reported	Class	Recall	Company	Reason	Where
3 Jun 2020	CLASS II	Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product recalled	Cardinal Health	Packaging Defects	OH
3 Jun 2020	CLASS II	Kangaroo 924 Safety Screw Spike Set, Product recalled by Cardinal Health	Cardinal Health	Packaging Defects	OH
3 Jun 2020	CLASS II	Kangaroo Joey Safety Screw Spike with Flush, Anti-free Flow, Product recalled	Cardinal Health	Packaging Defects	OH
3 Jun 2020	CLASS II	Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product recalled	Cardinal Health	Packaging Defects	OH
3 Jun 2020	CLASS II	Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product recalled	Cardinal Health	Packaging Defects	OH

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All 315

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