Recall Z-1777-2018 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Parker Laboratories, Inc.
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
| Date | Apr 13, 2017 |
| Status | Terminated |
| Reason | There is a potential for the gel packets to have leaks in the packet seal. |
| Root cause | Process control |
| Action | 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 i |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K802146 | AQUASONIC 100 ULTRASOUND TRANS. GEL, Parker Laboratories, Inc., Oct 10, 1980 |