Home / Recalls / Advance Medical Designs, Inc. / Z-2534-2023

Z-2534-2023 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
26900 units

Product Description

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

Reason for Recall

Ultrasound gel mislabeled with inappropriate use.

Distribution Pattern

US, Canada, UK, Panama, Netherlands

Code Information

a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279

Other recalls by Advance Medical Designs, Inc.

  • Z-2533-2023 Class II — 50-GEL20; Ultrasound gel (July 7, 2023)
  • Z-2535-2023 Class II — Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC (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-2532-2023 Class II — ASG-001; Ultrasound gel (July 7, 2023)