Titan Stabilizers and Titan 360 Stabilizers 의 안전성 경고

Safety alert

2015-01-23

2015-01-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150123.html

Medical device safety alert: terumo cvs titan stabilizers and titan 360 stabilizers medical device manufacturer, terumo cardiovascular systems (terumo cvs) corporation has issued a field safety notice concerning its titan stabilizers and titan 360 stabilizers, with the following details: catalogue number: 1) 401-231; 2) 401-231u lot number: 1) 052r; 2) 020r, 024r, 026r, 029r, 030r, 034r, 035r, 037r, 040r, 048r dates of distribution: 1) 29 march 2013 and 24 march 2014; 2) 7 august 2013 through 17 october 2014 the manufacturer is voluntarily recalling the above lots of titan stabilizers and titan 360 stabilizers because the suction tubing clip may break when it is being attached to the stabilizing arm. although the clip is for convenience purposes and is not required for device operation, there is a potential for broken suction tubing clip fragments to fall into the surgical site. a broken suction tubing clip could delay a surgical cardiac procedure as the surgeon replaces the unit or secures the suction tubing away from the surgical site by other means. if a suction tubing clip breaks and fragments fall into a patient’s body cavity during surgery, the event could lead to a delay in the procedure as the surgeon retrieves the component. this could be complicated by the fact that the clip fragments may have sharp edges and are not radiopaque. the manufacturer has determined that the suction tubing clip material weakened during a re-sterilisation process that occurred for the affected lots listed. the manufacturer’s current sterilisation process mitigates this risk. the manufacturer advises users to stop using titan stabilizers and titan 360 stabilizers from the affected lot numbers and return all affected product to the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 january 2015.