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Recalls and Alerts

Medical Device Recall: Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths   Medical device manufacturer, Boston Scientific, is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035” ID dilator may be labeled incorrectly as a 0.038” ID dilator. No injuries are expected to occur as a result of this mislabeling because the dilator would not be able to be advanced onto the guidewire. A delay in the procedure would occur while the physician exchanged devices. To date, Boston Scientific has received seven complaints related to this product issue. According to the local supplier, Hong Kong is NOT affected. For details, please refer to the attached Field Safey Notice. If you are in possession of the affected products, please contact supplier for necessary actions.

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Last revision date: 15 November 2011