One sample was received in used conditions, without its original packaging and with its certificate of safe handling.During the test, a leak was found in the cuff.The complaint is confirmed.The hole is observed with a circular shape with flash in the periphery.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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