FDA Warning: Infection Risks From
Contaminated Ultrasound Gel!
The Food and Drug Administration is warning doctors,
hospitals and clinics that contaminated ultrasound gel
produced by a New Jersey company
infected 16 cardiac patients and
could pose serious risks to pregnant women and
others who undergo ultrasound imaging and treatment.
The gel is used by radiologists, urologists,
gastroenterologists, OB-GYNs, internists,
nurses and ultrasound technicians
for diagnostic ultrasound testing.
Chiropractors and physical therapists
use the gel for therapeutic ultrasound treatment of pain,
inflammation and injuries.
Health professionals were urged to stop using
250 milliliter bottles and 5-liter dispensing containers
with three lot numbers: 060111, 090111 and 120111.
They were also asked to identify any patients who
underwent ultrasound exams with gel from those lots.
“This ultrasound gel presented serious health risks to
patients, particularly vulnerable ones,” Dara A. Corrigan,
the FDA’s associate commissioner for regulatory affairs,
said in a statement issued by the FDA.
“Therefore, FDA, with the assistance of our state partner,
is taking aggressive enforcement action
to protect the public health.”
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FDA Warning: Infection Risks From
Contaminated Ultrasound Gel!
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