Recall Z-0721-2024— Sarnova HC, Llc
Class II · Ongoing
Class II FDA medical device recall by Sarnova HC, Llc, initiated 2023-11-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Sarnova HC, Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-06
- Firm location
- Dublin, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.