Device product

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

Z-1777-2018

April 13, 2017

Class II

Product summary

Firm: Parker Laboratories, Inc.
Event: Event 79910
Status: Terminated
Classification: Class II
Quantity: 3275 cases/1310000 packets
Official record key: device-enforcement:Z-1777-2018

Official wording

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

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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