Recall Z-1777-2018— Parker Laboratories, Inc.

Name: FDA recall Z-1777-2018
Creator: U.S. Food and Drug Administration
Published: 2017-04-13

Class II · Terminated

Class II FDA medical device recall by Parker Laboratories, Inc., initiated 2017-04-13, terminated 2020-10-26. It names one FDA 510(k) clearance: K802146. Product: Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case. Reason: There is a potential for the gel packets to have leaks in the packet seal..

Recalling firm: Parker Laboratories, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Terminated: 2020-10-26
Firm location: Fairfield, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K802146 — AQUASONIC 100 ULTRASOUND TRANS. GEL,Parker Laboratories, Inc.·cleared 1980-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.