Recall Z-1130-2018 — Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the
U.S. FDA — Device Enforcement · United States · 2017-10-12 · Class II
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Reported risk: This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.
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