HPC—Model GN85 Violet Accelerator-Free Nitrile Examination Gloves: Defect May Cause Gloves to Smolder, Potentially Resulting in Fire
August 21, 2013 | Strategic Insights for Health System
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In an August 5, 2013, Urgent Field Safety Notice Medical Device Recall letter submitted by an ECRI Institute member hospital and posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), HPC states that a defect in the examination gloves below may result in a thermal reaction, causing them to become unstable. Initially the defect results in premature aging of the bead area, causing the gloves to become brittle and tear. The thermal reaction may cause accelerated heating of the gloves in the dispenser and, if tightly packed, may result in the gloves smoldering and potentially igniting when exposed to air. The manufacturer has not confirmed the...