Reported May 24, 2017 · Terminated
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating…
Del Mar Reynolds Medical, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Del Mar Reynolds Medical, Ltd. · 1 2 Harforde Court John Tate Road · Hertford · N/A
Is this the product you have?
- Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit
- part number050-9045-00. Absorber Adapter Assembly
- part number650-1648-01. Arkon Absorber Canister Carrier
- part number380-0916-01
- Lot codes and dates
- *********the serial numbers and part numbers of units distributed in the US ********* Absorber Adapter
- Assembly Service Kit part number050-9045-00
- Devices serial numbersARKN-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
- Amount recalled
- 62 total (US= 19 devices and 32 kits; International = 11 devices)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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