FDA Recall
Open, Classified
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
Recall: Z-0720-2024
·
Initiated November 6, 2023
Recall
- Recall Number
- Z-0720-2024
- Event Number
- 93665
- Firm
- Sarnova HC, Llc
- FEI Number
- 3014680755
- Product Code
- CAE
- Status
- Open, Classified
- Root Cause
- Mixed-up of materials/components
- Initiated
- November 6, 2023
- Posted
- January 12, 2024
- Address
- 5000 Tuttle Crossing Blvd, Dublin, OH, 43016-1534
Description
Curaplex Field Cric Kit with ET Tube, Item Number 36611. 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.
Action
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.
Distribution
US Nationwide
Quantity
1063 kits