Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197

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) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274;
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) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197

Product Codes/Lot Numbers:

a) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274;