AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Summary
The FDA issued a Class I for AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for by SonarMed Inc. Reason: The failure to detect the partial obstruction in a 2.5mm sensor..
Details
Source
Device Recall
External ID
Z-1521-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Lot/Code Info: 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, A20230131, A20230202, A20230206, A20230306, A20230307.
Quantity Affected: 500 units
Reason for Recall
The failure to detect the partial obstruction in a 2.5mm sensor.
Distribution
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-21
Company
Carmel, IN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SonarMed Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SonarMed Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SonarMed Inc have FDA actions?
SonarMed Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1521-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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