Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
This recall has been terminated (originally issued April 13, 2017).
- Company
- Parker Laboratories, Inc.
- Recall Initiated
- April 13, 2017
- Terminated
- October 26, 2020
- Recall Number
- Z-1777-2018
- Quantity
- 3275 cases/1310000 packets
- Firm Location
- Fairfield, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for the gel packets to have leaks in the packet seal.
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.
Lot / Code Info
Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006
Root Cause
Process control
Action Taken
Notification letters distributed 4/13/17 instructed customers to perform the following: We request that you quarantine any affected product in your inventory and contact Parker to discuss options for disposition of the recalled products in question. Should you identify any customers to whom the affected product may have already been distributed, we would be happy to provide you with a customer letter that can be transcribed onto your own company letterhead for the purposes of notifying them of this quality issue. Please completed the attached response form as soon as possible and return it to us at the email or fax number listed on the form, so that further arrangements can be made.