Recall Z-1653-2012
Pharmaceutical Innovations, Inc. · initiated March 2, 2012
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.
Codes / lots: 060111 080111 090111 100811
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: Employee error
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.
Details
- Recall number
- Z-1653-2012
- Initiated
- March 2, 2012
- Posted by FDA
- May 24, 2012
- Terminated
- July 19, 2021
- Product code
- MUI – Media, Coupling, Ultrasound
- Quantity
- 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.
- Recalling firm
- Pharmaceutical Innovations, Inc., Newark, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1652-2012 | Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a…Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination.… | 03/02/2012Terminated |