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U.S. Department of Health and Human Services

Class 1 Device Recall OtherSonic Generic Ultrasound Transmission Gel

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  Class 1 Device Recall OtherSonic Generic Ultrasound Transmission Gel see related information
Date Initiated by Firm March 02, 2012
Date Posted May 24, 2012
Recall Status1 Terminated 3 on July 19, 2021
Recall Number Z-1653-2012
Recall Event ID 61732
Product Classification Media,coupling,ultrasound - Product Code MUI
Product 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.
Code Information 060111 080111 090111 100811
Recalling Firm/
Manufacturer		 Pharmaceutical Innovations, Inc.
897 Frelinghuysen Ave
Newark NJ 07114-2122
For Additional Information Contact Mr. Gilbert Buchalter
973-242-2900
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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