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Del Mar Reynolds Medical, Ltd. recalls Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room
Recalled May 24, 2017 · FDA recall Z-2093-2017 · Del Mar Reynolds Medical
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. · FDA Class II
Units
62 total (US= 19 devices and 32 kits; International = 11 devices)
Sold at
US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
Description
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.
Product
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.
Manufacturer(s)
Del Mar Reynolds Medical, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →