Arrow—4 Fr Single-Lumen Pressure Injectable PICCs: IFU and Patient Card May State Incorrect Number of Pressure Injections That Product Can Withstand
October 7, 2015 | Strategic Insights for Health System
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In a September 22, 2015, Urgent Medical Device Notification letter submitted by an ECRI Institute member hospital, Arrow states that the instructions for use (IFU) and patient card packaged with the PICCs listed below may incorrectly state that the PICC can withstand up to 10 pressure injections; however, the PICCs have only been tested to withstand 5 pressure injections. Arrow also states that the...