FDA Medical Device Recalls (openFDA)
Del Mar Reynolds Medical, Ltd.: 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.
- Recall number
- Z-2093-2017
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2017-04-14
- Posted
- not on file
- Terminated
- 2017-10-16
- 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.
- Root cause
- Device Design
- Action
- Spacelabs sent an URGENT - MEDICAL DEVICE CORRECTION letter dated April 13, 2017, to US customers via priority service. The customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record on April 14, 2017. The letter announced that the The Arkon Anesthesia Delivery System, Model 99999, and the Absorber Adapter Assembly Kit part number 050-9045-00, and Absorber Adapter Assembly part number 650-1648-01 are being recalled. Customers are advised that The Arkon Anesthesia Delivery Systems Model 99999 with Absorber Adapter Assembly part number 650-1648-00 is NOT affected by this recall. Spacelabs Healthcare is developing a hardware upgrade to improve the robustness of the affected Absorber Adapter Assembly. A Spacelabs representative will contact consignees once the upgrade is available to schedule a convenient time to update their Arkon Anesthesia Delivery System(s) at no cost. For additional information or technical assistance, please contact: 1-800-522-7025 select 4 for Anesthesia Technical Support
- Quantity
- 62 total (US= 19 devices and 32 kits; International = 11 devices)
- Distribution
- US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
- Lot, serial or model codes
- *********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.
- 510(k) numbers
- ["K113051"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 3010157426
- Firm city
- Hertford
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28