CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report

Passport Series Patient Monitor intended for monitoring recalled

Mindray DS USA is recalling Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, distributed nationwide in the US. The recall was initiated on 23 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes100-00080-00 - 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

Quantity recalled360 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2549-2016
FDA event ID: 74704
Recalling firm: Mindray DS USA, Mahwah, NJ
Classification: Class II
Status: Terminated
Recall initiated: 23 Jun 2016
FDA classified: 16 Aug 2016
Reported: 24 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Patient Monitors

Timeline

23 Jun 2016	Recall initiated by company
16 Aug 2016	Classified by FDA	+54 days
24 Aug 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Nationwide, Canada

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide, Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Mindray DS USA

All 39

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24 Dec 2025Device	CLASS II	Hardware configuration of the BeneVision Central Monitoring recalled	Mindray DS USA	Device Malfunction	Nationwide
3 Dec 2025Device	CLASS II	The Anesthesia System is a device used to administer recalled	Mindray DS USA	Packaging Defects	Nationwide
3 Dec 2025Device	CLASS II	The Anesthesia System is a device used to administer recalled	Mindray DS USA	Packaging Defects	Nationwide
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11 Sep 2024Device	CLASS II	Sevoflurane E_Vap.(Quik-Fil):used recalled by Mindray DS USA	Mindray DS USA	Packaging Defects	8 states

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