Z-1777-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- April 13, 2017
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3275 cases/1310000 packets
Product Description
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 Pattern
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.
Code Information
Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006