Device recall
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
- Recall number
- Z-0144-2027
- Event id
- 99838
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Sarnova HC, Llc
- Report date
- Oct 21, 2026
- Posted
- Oct 9, 2026
- Initiated
- Jun 12, 2026
- Center classification date
- Oct 9, 2026
- Product code
- CCX
- Device type
- Support, Patient Position
- Reason
- Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
- Root cause
- Nonconforming Material/Component
- Quantity
- 2,500 kits
- Code info
- Lot ASM0043314 UDI-DI 00810094576127
- Distribution
- US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Dublin, OH, United States