Draeger Infinity Dual Hemo MCable Pod Recall for Liquid Ingress Risk
Draeger Medical Systems is recalling 2,760 Dual Hemo MCable Pods (Revisions 15 and 16) because they may allow liquid ingress, potentially causing incorrect invasive blood pressure readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to incorrect invasive blood pressure measurements, posing a risk of harm to patients, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Draeger Medical Systems, Inc. is recalling 2,760 units of the INFINITY DUAL HEMO MCable Pod, which are used with the Dräger Infinity Acute Care System. The affected products are identified by Revision Index (RI) 15 or 16, which can be found on the product label. The recall is due to a potential defect where the pods may permit liquid ingress that is inconsistent with their IPX4 rating.
This defect could potentially result in an incorrect measured value of invasive blood pressure. The affected products were distributed nationally. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should check their inventory for Dual Hemo MCable Pods with Revision Index 15 or 16. If these specific units are found, they should be removed from service and contacted with the recalling firm for instructions on return or replacement.
The recalled product
- Product
- INFINITY DUAL HEMO MCable Pod
- Manufacturer
- Draegar Medical Systems, Inc.
- Affected units
- 2,760
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 (1)
- Have the affected revision indexes: 15 or 16 (found on the product label)
Distribution
Distribution scope not specified by the agency.
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