PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: January 24, 2024 Initiated: November 6, 2023 #Z-0721-2024

Product Description

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.

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.

Details

Recalling Firm
Sarnova HC, Llc
Units Affected
15 kits
Distribution
US Nationwide
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sarnova HC, Llc. Units affected: 15 kits.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0721-2024.