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

FDA Recall #Z-1308-2024 — Class II — February 12, 2024

Recall #Z-1308-2024 Date: February 12, 2024 Classification: Class II Status: Ongoing

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

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.

Recalling Firm

Sarnova HC, Llc — Dublin, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

550 units

Distribution

US Nationwide distribution.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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