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Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish a...

FDA Recall #Z-1307-2024 — Class II — February 12, 2024

Recall #Z-1307-2024 Date: February 12, 2024 Classification: Class II Status: Ongoing

Product Description

Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S

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

540 kits

Distribution

US Nationwide distribution.

Code Information

UDI/GTIN: 00815277020008 each, 00810071639630 case Lot Numbers: ASM0038077 ASM0038129 ASM0038334 ASM0038598

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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