SonarMed 2.5mm Airway Sensor Recalled for Obstruction Detection Failure
SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity of Severe per the rubric. The device can fail to detect airway obstruction, a critical safety function. No illnesses or injuries are reported in the source text.
Plain-English summary
The AW-S025 NEO SONARMED SENSOR 2.5MM is an airway monitoring sensor manufactured by SonarMed Inc, designed to work in conjunction with the SonarMed Monitor for continuous patient airway observation in healthcare settings.
Approximately 610 units were distributed across 20 U.S. states: Alaska, Arizona, California, Florida, Illinois, Kentucky, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington.
The recall addresses a device failure wherein the 2.5mm sensor can fail to detect partial obstruction. When the obstruction detection function fails, clinicians may not receive alerts about compromised patient airways.
The affected serial numbers include batch codes from October 2022 through July 2023 (A20221012 through A20230725). The FDA has classified this as a Class I recall due to the serious potential for patient harm if airway obstruction goes undetected during patient monitoring.
The recalled product
- Product
- AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Manufacturer
- SonarMed Inc
- Hazard
- obstruction-detection-failure
- device-malfunction
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 (20)
- Product Number/CFN: AW-S025
- UDI-DI: 10851334007183
- Serial Numbers: A20221012
- A20221018
- A20221025
- A20221107
- A20221109
- A20221202
- A20221206
- A20221207
- A20221208
- A20221209
- A20230105
- A20230109
- A20230123
- A20230124
- A20230125
- A20230126
- A20230213
- A20230224
Distribution
Distributed in 19 states:
- AK
- AZ
- CA
- FL
- IL
- KY
- MD
- MO
- NC
- NJ
- NY
- OH
- OR
- PA
- SC
- TN
- TX
- VA
- WA
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