Advance Medical Designs, Inc.: 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

Hazard

Ultrasound gel mislabeled with inappropriate use.

Details from the source

Reason for recall: Ultrasound gel mislabeled with inappropriate use. Distribution: US, Canada, UK, Panama, Netherlands Quantity: 460 units Lot/code info: 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;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.