Reported Apr 24, 2024 · Ongoing
AW-S035 NEO SONARMED SENSOR 3.5MM. 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-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Lot codes and dates
- Product Number/CFNAW-S035
- UDI-DI10851334007206
- Serial Numbers
A20221012A20221019A20221026A20221109A20221110A20221111A20221114A20221212A20221213A20221214A20221215A20221216A20230110A20230111A20230112A20230113A20230116A20230130A20230131A20230202A20230206A20230306A20230307
- Amount recalled
- 500 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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