Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
FDA Recall Z-1653-2012 · Posted 2012-05-24
Recalling FirmPharmaceutical Innovations, Inc.
Recall StatusTerminated
Product CodeMUI
Date Initiated2012-03-02
Date Terminated2021-07-19
Product Quantity40,164 units in distribution worldwide - unable to obtain units in distribution Nationwide
Reason for Recall
Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012.
Firm Action
Phamaceutical Innovations Inc. sent an Urgent Message Notice letter dated March 02, 2012 with a followup letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 via email and fax to all affected customers. Customers were instructed to examinne inventory, refrain from distribution and return remaining inventory for a replacement. For questions call 973-242-2900.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.