CLASS II ONGOING Device recall · Reported 16 Nov 2022 · FDA Enforcement Report

Cardinal Health Hot And Cold Gel Pack Reusable, M, Cat recalled

Cardinal Health 200 is recalling Cardinal Health Hot And Cold Gel Pack Reusable, M, Cat, distributed nationwide in the US. The recall was initiated on 28 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled567475 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-0187-2023
FDA event ID: 90955
Recalling firm: Cardinal Health 200, Waukegan, IL
Classification: Class II
Status: Ongoing
Recall initiated: 28 Sep 2022
FDA classified: 7 Nov 2022
Reported: 16 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Sep 2022	Recall initiated by company
7 Nov 2022	Classified by FDA	+40 days
16 Nov 2022	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

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

Product as listed by the FDA

Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304

Where it was distributed

nationwide and Canada

Nationwide

Questions about this recall

Why was it recalled?

Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .

Which lots are affected?

All lots

Where was it sold?

nationwide and Canada

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

7 other products · FDA event 90955

This product is part of a recall event; the main page for the event is Cardinal Health Gel Pack Reusable, Small, Cat recalled.

Reported	Class	Recall	Company	Reason	Where
16 Nov 2022	CLASS II	Cardinal Health Gel Pack Reusable, Small, Cat recalled	Cardinal Health 200	Other	Nationwide
16 Nov 2022	CLASS II	Cardinal Health Insulated Gel Pack Reusable, Extra Large, Cat recalled	Cardinal Health 200	Other	Nationwide
16 Nov 2022	CLASS II	Cardinal Health Reusable Gel Pack, Hot/Cold Pack recalled	Cardinal Health 200	Other	Nationwide
16 Nov 2022	CLASS II	Cardinal Health Insulated Gel Pack Reusable, Small, Cat recalled	Cardinal Health 200	Other	Nationwide
16 Nov 2022	CLASS II	Cardinal Health Insulated Gel Pack Reusable, Medium, Cat recalled	Cardinal Health 200	Other	Nationwide
16 Nov 2022	CLASS II	Cardinal Health Gel Pack Reusable, Extra Small, Cat recalled	Cardinal Health 200	Other	Nationwide
16 Nov 2022	CLASS II	Cardinal Health Insulated Gel Pack Reusable, Large, Cat recalled	Cardinal Health 200	Other	Nationwide

More recalls from Cardinal Health 200

All 283

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide
9 Sep 2026Device	CLASS II	Presource Packs Containing CliniClean Pericare Wipes within recalled	Cardinal Health 200	Other	Nationwide

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