FDA recall Z-2536-2023

Product

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

Reason for recall

Ultrasound gel mislabeled with inappropriate use.

Distribution

US, Canada, UK, Panama, Netherlands

Key facts

Status

Ongoing

Initiation date

2023-07-07

Report date

2023-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2536-2023