Mindray Passport Series Patient Monitor CO2 Module Recall
Mindray is recalling Passport Series Patient Monitor CO2 Modules due to a potential leakage issue with the Dryline II Water Trap.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential leakage issue without reporting any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mindray DS USA, Inc. is recalling 360 units of the Passport Series Patient Monitor CO2 Module. The recall is due to a potential leakage issue with the Dryline II Water Trap used with the monitor.
The affected products were distributed nationwide and in Canada. The recall includes specific lot numbers: 1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606.
Healthcare facilities should stop using the affected CO2 Modules and contact Mindray for instructions on the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 360
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 (11)
- 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
Distributed nationwide across the United States.
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