CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
Curaplex Nasal Intubation Kit recalled by Sarnova HC
Sarnova HC is recalling Curaplex Nasal Intubation Kit with Endotrol Tube-To perform a nasal intubation to, distributed nationwide in the US. The recall was initiated on 12 Feb 2024 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-1307-2024
- FDA event ID
- 94116
- Recalling firm
- Sarnova HC, Dublin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Feb 2024
- FDA classified
- 19 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Feb 2024 | Recall initiated by company | |
| 19 Mar 2024 | Classified by FDA | +36 days |
| 27 Mar 2024 | 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
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Product as listed by the FDA
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Which lots are affected?
UDI/GTIN: 00815277020008 each, 00810071639630 case Lot Numbers: ASM0038077 ASM0038129 ASM0038334 ASM0038598
Where was it sold?
US Nationwide 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
1 other product · FDA event 94116This product is part of a recall event; the main page for the event is Curaplex Nasal Intubation Kit w/ Endotracheal Tube recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Curaplex Nasal Intubation Kit w/ Endotracheal Tube recalled | Sarnova HC | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recalled | Sarnova HC | Other | Nationwide |
| Device | CLASS II | Curaplex Nasal Intubation Kit w/ Endotracheal Tube 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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