Boston Scientific has issued a medical device safety alert concerning 3M Universal Electrosurgical Pads [SKU: SGP-082-100, SGP-080-40; Lot number: 2019-02DT, 2019-03DU, 2019-02DB; Expiration Date Range: 1 Feb 2019 to 1 Mar 2019], manufactured by 3M.
This recall follows confirmation of a single user report of an unintended material (process liner) in the product. The presence of a process liner may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site.
This removal affects only the lots listed in this notification. Further distribution or use of any remaining product affected by this action should cease immediately.
According to the local supplier (Boston Scientific), the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 March 2017