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The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.