Medical Devices
Pharmaceutical Innovations, Inc, Other-Sonic Generic Ultrasound Transmission Gel
Recall Class: Class I
Date Recall Initiated: March 2, 2012
Product: Other-Sonic Generic Ultrasound Transmission Gel.
Lots sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers.
Lot numbers:
- 060111
- 080111
- 090111
- 100811
Use: Other-Sonic Generic Ultrasound Transmission Gel is a non-sterile gel used in ultrasound procedures to improve the transmission and receiving of ultrasound waves.
Manufacturing Dates: June 2011 through December 2011.
Recalling Firm:
Pharmaceutical Innovations, Inc
897 Frelinghuysen Avenue
Newark, NJ 07114
Reason for Recall: Other-Sonic Generic Ultrasound Transmission Gel is being recalled due to possible microbial contamination that included organisms such as Pseudomonas aeruginosa and Klebsiella oxytoca.
Although this product is not labeled as either sterile or non-sterile, it is NOT sterile. The use of Other-Sonic Generic Ultrasound Transmission Gel may cause serious adverse health consequences, including death.
Public Contact: Customers with questions can contact the company at 973-242-2900.
FDA District: New Jersey
FDA Comments:
STOP using Other-Sonic Generic Ultrasound Transmission Gel from lot numbers 060111, 080111, 090111, 100811, and 120111..
Although lot 120111 was not voluntarily recalled by the firm, it has been added to the STOP using list because FDA testing revealed that this lot also contained Pseudomonas aeruginosa and Klebsiella oxytoca.
Pharmaceutical Innovations, Inc sent an Urgent Message Notice letter dated March 2, 2012 with a follow-up letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 by email and fax to all affected customers. Customers were instructed to examine their inventory, stop distributing this product, and return all remaining inventory for a replacement. For questions call 973-242-2900.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX.
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