Draeger Infinity Acute Care System Recall for Inaccurate Blood Pressure Readings
Draeger Medical is recalling 260 Infinity Acute Care System monitoring units because liquid ingress in the cable can cause inaccurate invasive blood pressure measurements.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device that provides inaccurate physiological measurements, which poses a significant risk of harm to patients.
Plain-English summary
Draeger Medical, Inc. is recalling 260 units of the Draeger Infinity Acute Care System (IACS) Monitoring Solution, Catalog Number MS20783 (Infinity MCable-Dual Hemo). These are physiological patient monitoring systems distributed in California, Illinois, and Massachusetts.
The recall is due to a defect where the displayed value for invasive blood pressure measurement may differ from actual patient values. This inaccuracy can occur if liquid enters the cable connection, which may happen if the Dual Hemo MCable is used in a non-vertical position, upside down, or laid on the floor or patient bed.
Healthcare facilities and users should stop using the affected cables and contact Draeger Medical for instructions on replacement or repair.
The recalled product
- Product
- Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- Affected units
- 260
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)
- Catalog Number MS20783 (Infinity MCable-Dual Hemo)
Distribution
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