Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emerge
Summary
The FDA issued a Class II for Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intuba by Sarnova HC, Llc. Reason: Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary mea.
Details
Source
Device Recall
External ID
Z-1308-2024
Action Date
2024-03-27
Status
Ongoing
Category
device
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
Lot/Code Info: UDI/GTIN: 00815277020015 each, 00810071639647 case Lot Numbers: ASM0038078 ASM0038130 ASM0038284 ASM0038395
Quantity Affected: 550 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-12
Company
Dublin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Sarnova HC, Llc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sarnova HC, Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sarnova HC, Llc have FDA actions?
Sarnova HC, Llc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1308-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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