Home / Recalls / Advance Medical Designs, Inc. / Z-2535-2023

Z-2535-2023 Class II Ongoing

Recalled by Advance Medical Designs, Inc. — Marietta, GA

Recall Details

Product Type
Devices
Report Date
September 20, 2023
Initiation Date
July 7, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
117875 units

Product Description

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

Reason for Recall

Ultrasound gel mislabeled with inappropriate use.

Distribution Pattern

US, Canada, UK, Panama, Netherlands

Code Information

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

Other recalls by Advance Medical Designs, Inc.

  • Z-2533-2023 Class II — 50-GEL20; Ultrasound gel (July 7, 2023)
  • Z-2537-2023 Class II — procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ (July 7, 2023)
  • Z-2536-2023 Class II — Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-E (July 7, 2023)
  • Z-2534-2023 Class II — Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-P (July 7, 2023)
  • Z-2532-2023 Class II — ASG-001; Ultrasound gel (July 7, 2023)