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.
What this means for you
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 (HR),
- 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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