The Recall Desk
HighFDA (Devices)·Z-2534-2023·Announced 2023-09-20

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.

What this means for you

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
  • mis-labeling

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.

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