Atlas FDA

Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of

FDA device recall Z-0720-2024 · posted 2024-01-12 · Open, Classified

Recall details

Recalling firm
Sarnova HC, Llc
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.
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.
Root cause
Mixed-up of materials/components
Status
Open, Classified
Product code
CAE
Quantity affected
1063 kits
Distribution
US Nationwide
Date initiated
2023-11-06
Date posted
2024-01-12
Location
Dublin, OH

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.