Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648

Class I - Dangerous

🏥 Medical Devices Recalled: July 7, 2023 Advance Medical Designs Other Medical Devices

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Advance Medical Designs, Inc.
Reason for Recall:: Ultrasound gel mislabeled with inappropriate use.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648

Product Codes/Lot Numbers:

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