Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its TLC Retractor Self-Retaining Retractor System.
Boston Scientific, as the distributor of the TLC Retractor Self-Retaining Retractor System, is implementing this Medical Device Recall at the request of Abeon Medical Corporation, the manufacturer and owner of these devices. Boston Scientific has been notified by Abeon Medical Corporation that certain lots of their products may contain open sterile pouch seals. In reported customer complaints, the pouch opening was obvious and discovered prior to use of the device. No injuries associated with open pouches have been reported.
According to Abeon's health risk assessment, the use of the device with an open pouch could result in a possible post-operative infection. Further distribution or use of any product affected by this removal should cease immediately.
According to the local supplier, 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 1 April 2016