Terumo Corporation has issued a medical device safety alert concerning its Radifocus Introducer II, Radifocus Introducer II M Coat and Glidesheath Slender. The affected products [Lot numbers (Product codes)] are listed as below:-
161027 (RS*B60N10MQ); 161104 (RM*AF6J10SQW); 161107 (RM*AF5J10SQW); 161109 (RM*AF4J16SQW); 161111 (RS*B50K10MQ, RS*B50N10SQ, RS*B70N10SQ); 161114 (RM*AF6J16SQW, RM*ES7F16SQR); 161115 (RM*AF6J16SQW, RM*ES7F10SQR, RS*B80N10MQ; 161124 (RM*ES6J16HQS); 161125 (RM*AF5J16SQW, RS*B60N10MQ); 161129 (RS*B70N10MQ); 161201 (RS*B50K10MQ); 161202 (RM*AF6J10SQW); 161206 (RM*ES6F16SQR, RM*ES6J16HQS, RS*B90N10SQ); 161207 (RM*AF6J16SQW, RM*ES7F16SQR); 161208 (RM*AF6J16SQW, RM*ES7F10SQR); 161212 (RS*B50N10SQ, RS*B60N10SQ); 161213 (RM*AF5J16SQW, RS*B70N10SQ, RS*B80N10MQ, RS*B80N10SQ); 161215 (RM*AF5J10SQW); 161220 (RS*B50N10MQ); 161222 (RS*B60N10MQ; 170111 RM*AF6J10SQW, RM*ES6F16SQR, RM*ES6J16HQS, RS*B50K10MQ, RS*B50N10MQ, RS*B50N10SQ); 170113 (RM*AF5J16SQW, RM*ES6J10HQS, RM*ES7F16SQR, RS*B90N10SQ): 170116 (RM*AF5J10SQW, RS*A60K10SQ); 170127 (RS*B60N10MQ); 170130 (RS*B70N10MQ); 170206 (RM*ES6F16SQR); 170208 (RM*ES7F16SQR); 170209 (RM*AF5J16SQW); 170227 (RM*AF6J25SQW); 170303 (RS*B60N25MQ)]
The manufacturer is conducting a global, voluntary recall of select lots of Radifocus Introducer II, Radifocus Introducer II M coat and Glidesheath Slender, which are used to support transradial intervention procedures.
The reason for the recall is a potential loss of package integrity that may compromise the sterility of the product. This issue was identified by Terumo during a routine inspection when an incomplete seal in the kit's peel pouch was observed. There have been no customer complaints or reported patient injuries associated to this issue .The potential defect rate is estimated to be less than 0.02%. The potential for patient harm is also low given the nature of the defect and impact on product performance.
Affected users should stop the use of all affected devices. The manufacturer will arrange product replacement for affected users.
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 24 May 2017