Mfr report # 9612638-2014-00002 details an issue that was identified in which a ring probe was taken from stock and inspected visually.It displayed a gap between the glue and the peek of the outer tube in the area where the ring channel and the outer tube are bonded together.Add'l ring probes were examined and mfr defects were identified.These defects consist of gaps between the upper and lower "shell halves of the ring probe, pin holes in the glue of the ring probe, and hairline cracks in the glue of the ring probe.Additionally, the sterilization process can cause cracks to form or widen.Due to their variable nature, these defects cannot be validated for efficacy of cleaning, disinfection and sterilization.As a result, use of the ring probes subjects users and pts to a risk of infection from a contaminated part.Based on varian's device applicability assessment, it was determined that the gm11000240 ring applicator 90 degree set and its components, gm11000220 ring probe 90, diameter 30 x 36mm, gm11000230 ring probe 90 degree, diameter 26mm x 32mm and gm1000210 ring probe 90 degree diameter 35mm x 41mm are also affected by this issue.
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