Z-0721-2024Class II

Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit...

Name: Z-0721-2024 Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit...
Creator: Sarnova HC, Llc
Published: 2023-11-06
License: https://open.fda.gov/license/

Sarnova HC, LLC / initiated 2023-11-06 / Open, Classified

FDA source

Sarnova HC, Llc began a recall of Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment... on 2023-11-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0721-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-06
Posted: 2024-01-12
Recalling firm: Sarnova HC, LLC
Product: 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.
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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.
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 15 kits
Distribution: US Nationwide
Product codes and lots: Lot Numbers: ASM0037685 ASM0037887

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0721-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0720-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12
Z-0721-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)