FDA recall Z-1777-2018

Product

Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case

Reason for recall

There is a potential for the gel packets to have leaks in the packet seal.

Distribution

The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.

Key facts

Status

Terminated

Initiation date

2017-04-13

Report date

2018-05-16

Termination date

2020-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1777-2018