Medical device recalls Moderate risk

Parker Laboratories, Inc. recalls Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case

Recall date
April 13, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1777-2018
FDA classification
Class II
Brand / firm
Parker Laboratories, Inc.
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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