News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
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Sunday, June 03, 2012
FDA Issues Class I Recall on Other-Sonic Ultrasound Gel
A Class I Recall was issued 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.
Customers are instructed to 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 containedPseudomonas aeruginosa and Klebsiella oxytoca.