Reported Apr 24, 2024 · Ongoing
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SonarMed Inc · 12220 N Meridian St Ste 150 · Carmel, IN · 46032-6972
Is this the product you have?
- AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Lot codes and dates
- Product Number/CFNAW-2030
- UDI-DI10851334007190
- Serial Numbers
A20221012A20221017A20221024A20221103A20221115A20221116A20221117A20221118A20221130A20221206A20221222A20221228A20221229A20230104A20230111A20230116A20230117A20230118A20230208A20230209A20230313A20230314A20230315A20230316A20230317A20230405
- Amount recalled
- 690 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
The failure to detect the partial obstruction in a 2.5mm sensor.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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