Draeger Infinity Acute Care System Recall for Alarm Failure
Draeger Medical Systems is recalling Infinity Acute Care System monitoring solutions because invasive pressure alarms may not activate.
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 3/5 (High).
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 where a safety-critical alarm function may fail, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Draeger Medical Systems, Inc. is recalling the Infinity Acute Care System (IACS) Monitoring Solution. The affected products include specific catalog numbers and UDI codes for multi-parameter physiologic patient monitoring systems used for adult, pediatric, and neonatal patients.
The recall is being issued because the invasive pressure visual and audible alarms may not activate. This system is intended to monitor patients in environments where care is provided by trained healthcare professionals.
The recall involves 28,317 total products distributed worldwide, including the United States and numerous international countries. Healthcare facilities should contact the manufacturer for further instructions on how to address the alarm functionality issue.
The recalled product
- Product
- Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751…
- Manufacturer
- Draegar Medical Systems, Inc.
- Hazard
- Affected units
- 28,317
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 (16)
- Catalog Number(s): MS18841
- MS20401
- MS20407
- MS20724
- MS22956
- MS25510
- MS25520
- MS25643
- MS26196
- MS26372
- MS31818
- UDI Information: 4049098054454
- 4049098054447
- 4049098054409
- 4049098009799
- 4049098009751
Distribution
Distributed nationwide across the United States.
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