CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP recalled
Sarnova HC is recalling Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 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
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-0721-2024
- 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 Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
Where it was distributed
US Nationwide
Questions about this recall
Is Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP recalled?
Yes. Sarnova HC recalled Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP on 6 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0721-2024.
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: ASM0037685 ASM0037887
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 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.
More recalls from Sarnova HC
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Curaplex Nasal Intubation Kit recalled by Sarnova HC | Sarnova HC | Other | Nationwide |
| Device | CLASS II | Curaplex Nasal Intubation Kit w/ Endotracheal Tube-To recalled | Sarnova HC | Other | Nationwide |
| Device | CLASS II | Curaplex Field Cric Kit with ET Tube recalled by Sarnova HC | Sarnova HC | Other | Nationwide |
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