Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Summary
The FDA issued a Class II for Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-P by Advance Medical Designs, Inc.. Reason: Ultrasound gel mislabeled with inappropriate use..
Details
Source
Device Recall
External ID
Z-2534-2023
Action Date
2023-09-20
Status
Ongoing
Category
device
Product Description
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Lot/Code Info: a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279
Quantity Affected: 26900 units
Reason for Recall
Ultrasound gel mislabeled with inappropriate use.
Distribution
US, Canada, UK, Panama, Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-07
Company
Marietta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Advance Medical Designs, Inc. has 7 FDA actions in our database, including 6 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Advance Medical Designs, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advance Medical Designs, Inc. have FDA actions?
Advance Medical Designs, Inc. has 7 FDA actions in our database, including 6 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2534-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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