FDAClass IIMay 16, 2018

Sterile Aquasonic 100 Ultrasound Transmission Gel recall

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

Why was Sterile Aquasonic 100 Ultrasound Transmission Gel recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006

Product
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Recalling firm
Parker Laboratories, Inc.
Quantity
3275 cases/1310000 packets
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.
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls