Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Summary
The FDA issued a Class II for Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Numbe by Sarnova HC, Llc. Reason: Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula..
Details
Source
Device Recall
External ID
Z-0144-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Lot/Code Info: Lot ASM0043314 UDI-DI 00810094576127
Quantity Affected: 2,500 kits
Reason for Recall
Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
Distribution
US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-12
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 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Sarnova HC, Llc has 5 FDA actions in our database, including 5 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 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0144-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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