Alerta De Seguridad para Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ’75, and Pereyra-Raz Ligature Carrier

Safety alert

2017-04-25

2017-04-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170425.html

Medical device safety alert: cook medical stamey needle, clarke-reich laparoscopic knot pusher, endoscopic introducer/extractor, pereyra ligature carrier ’75, and pereyra-raz ligature carrier medical device manufacturer, cook medical, has issued a medical device safety alert concerning its stamey needle, clarke-reich laparoscopic knot pusher, endoscopic introducer/extractor, pereyra ligature carrier ’75, and pereyra-raz ligature carrier. [catalogue identifiers: 1) j-syn-931630, j-syn-931615, j-syn-931600, 095030, 095015, 095000; 2) j-crkp-042900; 3) j-eie-051500; 4) j-plc-751810, 090100; 5) j-rsn-901600, 090002; lot numbers: all ]. the manufacturer has identified the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. their preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. there have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization associated with these devices. potential adverse events that may occur if the products are not adequately reprocessed include localized surgical site infection to deeper organ space infection as well as chemical residual exposure. the manufacturer advises users to examine inventory immediately to determine if they have affected products and quarantine affected products. return or discard any affected products. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 april 2017.