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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77019

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 14, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Del Mar Reynolds Medical, Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2093-2017
Recall number
Z-2093-2017
Initiated
April 14, 2017
Classification
Class II
Status
Terminated
Quantity
62 total (US= 19 devices and 32 kits; International = 11 devices)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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.

Distribution pattern

US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.

Field note

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