Z-1777-2018Class II

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

Name: Z-1777-2018 Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Creator: Parker Laboratories, Inc.
Published: 2017-04-13
License: https://open.fda.gov/license/

Parker Laboratories, Inc. / initiated 2017-04-13 / Terminated / root cause: manufacturing process

FDA source

Parker Laboratories, Inc. began a recall of Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case on 2017-04-13. FDA classified it as Class II and gives the reason as "There is a potential for the gel packets to have leaks in the packet seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1777-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Posted: 2018-05-09
Terminated: 2020-10-26
Recalling firm: Parker Laboratories, Inc.
Product: Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: There is a potential for the gel packets to have leaks in the packet seal.
Root cause tag: manufacturing process
FDA 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 it to us at the email or fax number listed on the form, so that further arrangements can be made.
Quantity in commerce: 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.
Product codes and lots: Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1777-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1777-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-09

Product code IYO

K802146Class IIAquasonic 100 Ultrasound Trans. Gel,Parker Laboratories, Inc. / cleared 1980-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)