Recall Z-0731-2015 — PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used
U.S. FDA — Device Enforcement · United States · 2014-11-17 · Class II
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Reported risk: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
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