FDA Recall Open, Classified

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.

Recall: Z-0721-2024 · Initiated November 6, 2023

Recall

Recall Number
Z-0721-2024
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 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.

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

15 kits