Recall Z-2093-2017— Del Mar Reynolds Medical, Ltd.

Name: FDA recall Z-2093-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-14

Class II · Terminated

Class II FDA medical device recall by Del Mar Reynolds Medical, Ltd., initiated 2017-04-14, terminated 2017-10-16. It names one FDA 510(k) clearance: K113051. 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.. Reason: 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..

Recalling firm: Del Mar Reynolds Medical, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2017-04-14
Terminated: 2017-10-16
Firm location: Hertford, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K113051 — SPACELABS ARKON ANESTHESIA WORKSTATIONSpacelabs Healthcare·cleared 2012-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.