Procedural kits with ultrasonic transmission gel recalled for mislabeling
Advance Medical Designs, Inc. is recalling 26,900 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The affected products were distributed in the U.S., Canada, the UK, Panama, and the Netherlands.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for mislabeling of proper use instructions. Mislabeled medical device use information creates a risk of improper use, meeting the rubric criterion for 'High' (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Advance Medical Designs, Inc. is recalling procedural kits containing ultrasonic transmission gel with Item Numbers 20-PMT03 and 20-PMT04. The recall involves 26,900 units, with lot numbers 30479C3299 for Item 20-PMT03 and 30394C3279 for Item 20-PMT04.
The kits are being recalled because they are mislabeled with information about inappropriate use.
The affected products were distributed in the United States, Canada, the United Kingdom, Panama, and the Netherlands.
The recalled product
- Product
- Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
- Manufacturer
- Advance Medical Designs, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 26,900
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 (3)
- a) 20-PMT03
- Lot Numbers: 30479C3299 b) 20-PMT04
- Lot Numbers: 30394C3279
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Advance Medical Designs, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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