Z-2093-2017 Class II Terminated
FDA device recall Z-2093-2017 was initiated by Del Mar Reynolds Medical, Ltd. on April 14, 2017 and is designated Class II. 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. The recall status is terminated (terminated October 16, 2017). Affected quantity: 62 total (US= 19 devices and 32 kits; International = 11 devices).
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 14, 2017
- Termination Date
- October 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 total (US= 19 devices and 32 kits; International = 11 devices)
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.
Distribution Pattern
US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
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.