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Terminated

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

FDA Recall Z-1777-2018 · Posted None

Recalling FirmParker Laboratories, Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2017-04-13
Date Terminated2020-10-26
Product Quantity3275 cases/1310000 packets

Reason for Recall

There is a potential for the gel packets to have leaks in the packet seal.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K802146AQUASONIC 100 ULTRASOUND TRANS. GEL,Parker Laboratories, Inc. · 1980-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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