Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-sterile gel used in ultraso

FDA device recall Z-1652-2012 · posted 2012-05-24 · Terminated

Recall details

Recalling firm

Pharmaceutical Innovations, Inc.

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.

Action taken

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

Status

Terminated

Product code

MUI

Quantity affected

40,164 units in distribution worldwide - unable to obtain units in distribution Nationwide

Distribution

Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.

Date initiated

2012-03-02

Date posted

2012-05-24

Date terminated

2021-07-19

Location

Newark, NJ