Skip to content

Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To… recallZ-1308-2024 · Sarnova HC, Llc · initiated Feb 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sarnova HC, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

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

Recall details

Recall number
Z-1308-2024
Status
Open, Classified
Initiated by the company
Feb 12, 2024
Posted by the FDA
Mar 19, 2024
Recalling firm
Sarnova HC, Llc
Quantity
550 units
Product code
LNZ
Distribution
US Nationwide distribution.

Product description

Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S

Code information (models, lots, serial numbers)

UDI/GTIN: 00815277020015 each, 00810071639647 case Lot Numbers: ASM0038078 ASM0038130 ASM0038284 ASM0038395

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94116).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page