FDA-Device2017-05-24Class II
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.
Del Mar Reynolds Medical, Ltd.
Hazard
Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
Sold states
US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
Affected count
62 total (US= 19 devices and 32 kits; International = 11 devices)
Manufactured in
1 2 Harforde Court John Tate Road, Business Park, Hertford, United Kingdom
Products
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2093-2017Don't want to check this manually?
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