Del Mar Reynolds Medical, Ltd.: Medical Device Recall in 2017 - (Recall #: Z-2093-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 14, 2017

Date Posted: May 24, 2017

Recall Number: Z-2093-2017

Event ID: 77019

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.

Status: Terminated

Product Quantity: 62 total (US= 19 devices and 32 kits; International = 11 devices)

Code Information:

*********the serial numbers and part numbers of units distributed in the US ********* Absorber Adapter Assembly Service Kit part number: 050-9045-00. Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413. *********the serial numbers of units distributed international ************************** ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated