FDA Device recall Z-1777-2018
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case by Parker Laboratories, citing there is a potential for the gel packets to have leaks in the packet seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1777-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-13 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Parker Laboratories |
| Distribution | CA, FL, GA, IA, IL, OH, TN, VA |
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.
Identifiers
| code_info | Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1777-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.