Z-0144-2027 Class II Ongoing
FDA device recall Z-0144-2027 was initiated by Sarnova HC, Llc on Jun 12, 2026 and is designated Class II. Reason for recall: Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula. The recall status is ongoing. Affected quantity: 2,500 kits.
Recall details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Jun 12, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,500 kits
Product description
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Reason for recall
Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
Distribution pattern
US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
Code information
Lot ASM0043314 UDI-DI 00810094576127
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0144-2027
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026