Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Flexor Check-Flo Introducer and Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select). The affected devices are identified as follows:
The manufacturer is voluntarily recalling specific lots of the Flexor Check-Flo Introducer and Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select). The affected products were distributed from March 23, 2020 through November 17, 2020. For the impacted product lots, the manufacturer has identified that there is an increased likelihood of the introducer sheath separating at the proximal bond site.
If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Users are instructed to examine their inventory immediately to determine if they have the affected product(s) and quarantine any affected product that remains unused. Distribution and use of the affected product should be ceased immediately. The manufacturer is removing devices potentially impacted from the market and product recall is on-going. Additionally, an investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 26 November 2020