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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74704

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

Open FDA event record

Event summary

Timeline bucket
June 23, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mindray DS USA, Inc. dba Mindray North America

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

Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.

Z-2549-2016
Recall number
Z-2549-2016
Initiated
June 23, 2016
Classification
Class II
Status
Terminated
Quantity
360 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

Code information

100-00080-00 - Dyrline II Water Trap, Adult 115-020919-00- CO2 Module with Accessory Kit, Adult and Pediatric Lot #1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606

Distribution pattern

Nationwide, Canada

Field note

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