Del Mar Reynolds Medical, Ltd. recalls Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating roo…

Recall date

April 14, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2093-2017

FDA classification

Class II

Brand / firm

Del Mar Reynolds Medical, Ltd.

Sold / distributed

US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.