Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
This recall is currently active, issued January 12, 2024. It was issued by Sarnova Hc, Llc.
- Company
- Sarnova Hc, Llc
- Recall Initiated
- November 6, 2023
- Posted
- January 12, 2024
- Recall Number
- Z-0720-2024
- Quantity
- 1063 kits
- Firm Location
- Dublin, OH
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide
Lot / Code Info
Lot Numbers: ASM0037579 ASM0037631 ASM0037905 ASM0038197
Root Cause
Mixed-up of materials/components
Action Taken
An URGENT: MEDICAL DEVICE RECALL notification letter dated 11/6/23 was sent to customers. Should you determine your inventory contains product covered by this recall, please immediately quarantine your affected product and contact Bound Tree Medical Customer Care to arrange for a return of the product in exchange for a credit.