FDA-Device2018-05-16Class II
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Parker Laboratories, Inc.
Hazard
There is a potential for the gel packets to have leaks in the packet seal.
Sold states
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.
Affected count
3275 cases/1310000 packets
Manufactured in
286 Eldridge Rd, N/A, Fairfield, NJ, United States
Products
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1777-2018Don't want to check this manually?
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