According to a report of Gore Industrial Products Trade (Shanghai) Co., Ltd, due to labeling mistakes, the manufacturers Gore Industrial Products Trade (Shanghai) Co., Ltd and Tongren Co., Ltd initiated the voluntary recall of specific batches of hydrophilic coated guiding sheath. The recall is identified as a Class II recall. For details on product models, specifications and batches, see the Report Form of Medical Device Recall.

Attachment: Report Form of Medical Device Recall

December 11，2019