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The recalled youth hooded fleece garments have drawstrings. They were sold in a variety of colors and many of them have the names of colleges and universities printed or embroidered on them. A sewn-in tag reads, "Lil Fan" or "LF 2."
In the cardiac measurement section of the device the calculation of the 'PG Mean' (mean pressure gradient) leads to an erroneous result. It is recommended that customers with affected units do not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG Mean' values should not be included in any patient documentation.