Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides health
FDA device recall Z-0721-2024 · 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
- 15 kits
- Distribution
- US Nationwide
- Date initiated
- 2023-11-06
- Date posted
- 2024-01-12
- Location
- Dublin, OH
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