Pyng Medical Corp. Initiates Voluntary Recall of the FASTx(TM)
Published: Nov 16, 2010
VANCOUVER, BRITISH COLUMBIA--(Marketwire - November 16, 2010) - Pyng Medical (TSX VENTURE: PYT) announced today that it has initiated a voluntary recall of the FASTx™ Sternal Intraosseous Device. Pyng received feedback regarding inconsistent performance of FASTx™ in several early training sessions that were conducted and, as a result, recalled the first 400 devices shipped to distributors. Pyng has discontinued shipment of future devices until it can evaluate these happenings and determine root cause.
"This voluntary recall was initiated because it is simply the right thing to do when there is any question regarding the performance of a medical device," said Mark Hodge, President and CEO of Pyng, in a statement related to the company's action. "The Pyng technical team is working rapidly to analyze these events and determine a course of action. We will ensure that the FASTx™ Sternal Intraosseous Device is performing as we expect it to perform and will provide ongoing updates."
The revolutionary clinical benefits available through utilization of the FAST1® Sternal Intraosseous Device will not be impacted by this voluntary action. During this period of FASTx™ evaluation, the FAST1® continues to ship to customers desiring the benefits of sternal IO, anatomical land marking, automatic depth control, and secure placement.
About Pyng Medical Corp.
Pyng Medical Corp. commercializes award-winning trauma and resuscitation products for front-line critical care personnel. Pyng's expanded product portfolio includes a variety of innovative, lifesaving tools. With growing markets in North America, Europe and Asia, Pyng offers user-preferred medical devices for use by hospital staff, emergency medical services and military forces worldwide.
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Pyng Medical Corp.
Mark F. Hodge
Chief Executive Officer