Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has released an urgent field safety notice recalling select Intraluminal Staplers distributed in the UK and Ireland over issues with the devices that may affect their performance during surgeries.
Ethicon said that after investigating complaints and returned products, it confirmed the occurrence of uncut washers and malformed staples within the recalled devices which the company said can compromise staple line integrity.
Problems with the staple line can lead to a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage or hemorrhagic shock, the company said.
Ethicon said that based on its analysis of complaints, the occurrence of malformed staples or uncut washers has increased but is expected to be below 0.1%.
The recall affects 247 lots of Intraluminal Staplers with product codes ECS21A, ECS25A, ECS29A, ECS33A, CDH21A, CDH25A, CDH29A and CDH33A, Ethicon said in its urgent field safety notice.
The company instructed customers to return all products affected by the notification if they have alternative products available. If alternative products are not available, Ethicon provided steps to take to reduce the risk associated with the malfunction.
Earlier this month, Ethicon released a notice it filed in the Europe, the Middle East and Africa region warning of issues with its Intraluminal Staplers related to malformed staples and uncut washers.
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