Miami, Florida, October 20, 2010
STAT Medical Devices, Inc.® has been granted a formal termination of the voluntary recall of their insulin pen needles from the Food & Drug Administration, Department of Health and Human Services. The affected products include STAT’s Super-FineTM – Micro, Xtra and Standard, as well as Allison Medical, Inc.’s SureComfort – Mini, Short and Standard Pen Needles.
In June of 2009 the FDA raised concerns that the silicone coating on the insulin pen needles manufactured by STAT Medical Devices had not been formally cleared by the agency. STAT took immediate action and on June 18, 2009 issued a voluntary, Urgent Medical Device Recall Notification letter to direct customers, requesting a return of all affected products and that these customers send notification to all end-users that may have received the recalled items. The total number of products affected by the recall was 6,424,100.
“We take product quality and customer safety issues extremely serious,” says Mary L. Jean, CQA, Director of Quality & Regulatory Affairs – SMD. “We’re very happy that our swift actions have resulted in the FDA issuing a recall closure letter in which they state ‘no further effectiveness checks are necessary’.”
STAT Medical Devices is a Miami-based designer/manufacturer of a complete line of clinical and home-use blood sampling devices for global distribution. In addition to OEM (custom design) services, STAT’s line of products is available for Private Labeling.
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STAT Medical Devices, Inc.®
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