TWISTER PLUS Rotatable Retrieval Device 22mm and 26mm (used in flexible endoscopes as a retrieval device for foreign bodies, such as polyps and food boluses)
모델명 / 제조번호(시리얼번호)
TWISTER PLUS Rotatable Retrieval Device 22mm and 26mm (used in flexible endoscopes as a retrieval device for foreign bodies, such as polyps and food boluses)Catalogue Numbers: 6141 and 6142Material Number: M00561410, M00561411, M00561412, M00561420, M00561421, M00561422Multiple Lot numbers affectedExpiration date: 31 July 2015 to 30 September 2015ARTG Number: 166708
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”