Procedural Kits with Ultrasonic Gel Recalled for Inappropriate Use Labeling
Advance Medical Designs is recalling 117,875 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The recall affects kits distributed to the United States, Canada, United Kingdom, Panama, and Netherlands.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or patient harm. The defect is a labeling error regarding appropriate use, which constitutes a minor labeling error per the severity rubric.
Plain-English summary
Advance Medical Designs, Inc. is recalling procedural kits containing ultrasonic transmission gel distributed to the United States, Canada, United Kingdom, Panama, and Netherlands. The affected kits include five item numbers with the following lot numbers: 20-PC424 (lot 21109C2345), 20-PC448 (lot 30371C3276), 20-PC548 (lots 21088C2341 and 30353C3268), 20-PC596 (lots 20622C2244 and 30481C3301), and 20-PC648 (lots 20145C2088 and 20163C2097). A total of 117,875 units are included in this recall.
The recall is due to the product being mislabeled with inappropriate use instructions. This labeling error could result in the ultrasonic gel being used in procedures or applications for which it is not intended.
Healthcare providers, medical facilities, and end users who have received these kits should stop using the affected products and contact Advance Medical Designs, Inc. for replacement products with correct labeling.
The recalled product
- Product
- Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
- Manufacturer
- Advance Medical Designs, Inc.
- Category
- Medical Device — Ultrasound Gel
- Hazard
- mislabeling
- improper-use
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 (13)
- a) 20-PC424
- Lot Numbers: 21109C2345
- b) 20-PC448
- Lot Numbers: 30371C3276
- c) 20-PC548
- Lot Numbers: 21088C2341
- 30353C3268
- d) 20-PC596
- Lot Numbers: 20622C2244
- 30481C3301
- e) 20-PC648
- Lot Numbers: 20145C2088
- 20163C2097
Distribution
Distribution scope not specified by the agency.
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