FDA Recalls SonarMed Airway Sensor for Obstruction Detection Failure
SonarMed Inc is recalling the AW-S035 NEO airway monitoring sensor due to failure to detect partial obstructions. The defect may prevent the device from alerting clinicians to airway obstruction.
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: FDA Class I classification mandates a minimum severity score of 4. The failure to detect airway obstruction in a monitoring device creates serious patient safety risk. No illnesses or deaths are reported in the source.
Plain-English summary
SonarMed Inc is recalling 500 units of the AW-S035 NEO SONARMED SENSOR 3.5MM, an airway monitoring sensor used with the SonarMed Monitor.
The FDA issued a Class I recall because the sensor may fail to detect partial airway obstruction, preventing the device from alerting clinicians to the presence of airway obstruction.
The recalled sensors were distributed to healthcare facilities in Alaska, Arizona, California, Florida, Illinois, Kentucky, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington. Affected units have specific serial numbers from production batches dated in 2022 and 2023.
Healthcare facilities should verify any AW-S035 sensors against the affected serial numbers and contact SonarMed Inc for replacement or further instructions. Units matching the recalled serial numbers should not be used.
The recalled product
- Product
- AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Manufacturer
- SonarMed Inc
- Hazard
- obstruction-detection-failure
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-S035
- UDI-DI: 10851334007206
- Serial Numbers: A20221012
- A20221019
- A20221026
- A20221109
- A20221110
- A20221111
- A20221114
- A20221212
- A20221213
- A20221214
- A20221215
- A20221216
- A20230110
- A20230111
- A20230112
- A20230113
- A20230116
- A20230130
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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