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U.S. Department of Health and Human Services

Class 2 Device Recall Arkon Anesthesia Delivery System

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  Class 2 Device Recall Arkon Anesthesia Delivery System see related information
Date Initiated by Firm April 14, 2017
Create Date May 16, 2017
Recall Status1 Terminated 3 on October 16, 2017
Recall Number Z-2093-2017
Recall Event ID 77019
510(K)Number K113051  
Product Classification Gas-machine, anesthesia - Product Code BSZ
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.
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.
Recalling Firm/
Manufacturer		 Del Mar Reynolds Medical, Ltd.
1 2 Harforde Court John Tate Road
Business Park
Hertford United Kingdom
For Additional Information Contact
800-522-7025 Ext. 4
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = SPACELABS HEALTHCARE
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