Z-1308-2024Class II

Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway...

Name: Z-1308-2024 Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway...
Creator: Sarnova HC, Llc
Published: 2024-02-12
License: https://open.fda.gov/license/

Sarnova HC, LLC / initiated 2024-02-12 / Open, Classified / root cause: design

FDA source

Sarnova HC, Llc began a recall of Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S on 2024-02-12. FDA classified it as Class II and gives the reason as "Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation 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, and MDM tags the root cause as design.

Recall record

Recall number: Z-1308-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-12
Posted: 2024-03-19
Recalling firm: Sarnova HC, LLC
Product: Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
Product code: LNZ Changer, Tube, Endotracheal
Reason for recall: Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Root cause tag: design
FDA root cause: Component design/selection
Action: Bound Tree issued URGENT NOTICE OF RECALL letters on February 12, 2024 via USPS Letter to Medical Inventory Controls/Supplies Coordinator/Buyer. Letter states reason for recall, health risk and actin to take: Should you determine your inventory contains product covered by this recall, please immediately quarantine your affected product and contact Bound Tree Medical Customer Care at 800.533.0523 to arrange for a return of the product in exchange for a credit
Quantity in commerce: 550 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/GTIN: 00815277020015 each, 00810071639647 case Lot Numbers: ASM0038078 ASM0038130 ASM0038284 ASM0038395

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1308-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1307-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19
Z-1308-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19

Product code LNZ

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)