CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report

Curaplex Field Cric Kit with ET Tube recalled by Sarnova HC

Sarnova HC is recalling Curaplex Field Cric Kit with ET Tube, distributed nationwide in the US. The recall was initiated on 6 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: ASM0037579 ASM0037631 ASM0037905 ASM0038197

Quantity recalled1063 kits

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-0720-2024
FDA event ID: 93665
Recalling firm: Sarnova HC, Dublin, OH
Classification: Class II
Status: Ongoing
Recall initiated: 6 Nov 2023
FDA classified: 12 Jan 2024
Reported: 24 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Nov 2023	Recall initiated by company
12 Jan 2024	Classified by FDA	+67 days
24 Jan 2024	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

It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

Product as listed by the FDA

Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Numbers: ASM0037579 ASM0037631 ASM0037905 ASM0038197

Where was it sold?

US Nationwide

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

1 other product · FDA event 93665

This product is part of a recall event; the main page for the event is Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP recalled.

Reported	Class	Recall	Company	Reason	Where
24 Jan 2024	CLASS II	Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP recalled	Sarnova HC	Other	Nationwide

More recalls from Sarnova HC

All 4

Reported	Class	Recall	Company	Reason	Where
27 Mar 2024Device	CLASS II	Curaplex Nasal Intubation Kit recalled by Sarnova HC	Sarnova HC	Other	Nationwide
27 Mar 2024Device	CLASS II	Curaplex Nasal Intubation Kit w/ Endotracheal Tube recalled	Sarnova HC	Other	Nationwide
24 Jan 2024Device	CLASS II	Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP recalled	Sarnova HC	Other	Nationwide

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