Spacelabs Arkon Anesthesia Delivery System Canister Carrier Recall
Del Mar Reynolds Medical is recalling 62 Spacelabs Arkon Anesthesia Delivery System components because the canister carrier can break, causing a breathing circuit leak and potential patient hypoventilation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (anesthesia delivery system) where injury (hypoventilation) has not yet been reported, fitting the High severity criteria.
Plain-English summary
Del Mar Reynolds Medical, Ltd. is recalling the Spacelabs Healthcare Arkon Anesthesia Delivery System Absorber Adapter Assembly Service Kit, Absorber Adapter Assembly, and Arkon Absorber Canister Carrier. The recall involves 62 total units, including 19 devices and 32 kits distributed in the United States, and 11 devices distributed internationally to Panama and the United Kingdom. US distribution occurred in Florida, Louisiana, Mississippi, North Carolina, South Carolina, and Wyoming.
The recall was initiated due to reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit. This breakage can cause a leak in the breathing circuit, which could result in hypoventilation in the patient. The affected components include the Absorber Adapter Assembly Service Kit (part number 050-9045-00), the Absorber Adapter Assembly (part number 650-1648-01), and the Arkon Absorber Canister Carrier (part number 380-0916-01).
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the recall documentation. US-distributed devices have serial numbers ranging from ARKN-000395 to ARKN-000413. International units have serial numbers ARKN-000375 and ARKN-000414 through ARKN-000423. Users should contact the recalling firm for instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- ARKN-000414
- ARKN-000415
- ARKN-000416
Distribution
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