FDA Medical Device Recalls (openFDA)
Parker Laboratories, Inc.: Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
- Recall number
- Z-1777-2018
- Recalling firm
- Parker Laboratories, Inc.
- Product
- Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
- Status
- Terminated
- Initiated
- 2017-04-13
- Posted
- not on file
- Terminated
- 2020-10-26
- 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 it to us at the email or fax number listed on the form, so that further arrangements can be made.
- 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.
- Lot, serial or model codes
- Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006
- 510(k) numbers
- K802146
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 2212018
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28