FDA-Device2026-10-21Class IIPROCESSING DEFECT
Sarnova Curaplex Capnography Cannula Multipack recalled for wrong cannula size in kit
What this means
Sarnova HC assembled some Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipacks (10-pack, Item 670272-KIT, Lot ASM0043314) with pediatric nasal cannulas instead of adult nasal cannulas. This size mismatch could result in incorrect gas sampling or fit during use. About 2,500 kits were distributed across the Midwest and Mountain regions.
- Check if you have Item 670272-KIT, Lot ASM0043314 with UDI-DI 00810094576127.
- Do not use affected kits for adult patients; pediatric cannulas are not the correct size.
- Contact Sarnova or your supplier for instructions on replacement or return.
The agency's original wording
Hazard
Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
Affected count
2,500 kits
Manufactured in
5000 Tuttle Crossing Blvd, Dublin, OH, United States
Products
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0144-2027Want us to check the next one for you?
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