Horizons International TWISTER PLUS Rotatable Retrieval Device 의 안전성 경고

Safety alert

2013-11-22

2013-11-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131122.html

Medical device safety alert: horizons international twister plus rotatable retrieval device boston scientific, as the distributor of the twister plus rotatable retrieval device initiated a recall of the device in coordination with horizons international corporation which is the manufacturer of the device. the affected catalogue number, material number and lots/batches as follows: twister plus rotatable retrieval device - 22mm (box of 1) : catalogue number 6141, material number m00561410, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 22mm (box of 5) : catalogue number 6141, material number m00561411, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 22mm (box of 10): catalogue number 6141, material number m00561412, lot/batch number h13061101, h13062403, h13062404, h13071301 twister plus rotatable retrieval device - 26mm (box of 1): catalogue number 6142, material number m00561420, lot/batch number h13061102, h13061103, h13061104, h13062401, h13062402, h13071302, h13082603 twister plus rotatable retrieval device - 26mm (box of 5): catalogue number 6142, material number m00561421, lot/batch number h13061102, h13061103, h13061104, h13062401, h13082603 twister plus rotatable retrieval device - 26mm (box of 10): catalogue number 6142, material number m00561422, lot/batch number h13061102, h13061104, h13062401, h13062402, h13071302, h13082603 it has come to the attention of boston scientific that the packages of certain lots/batches of twister plus may not be fully sealed, affecting the sterility of the device. use of a retrieval device from a package with an open seal may impart a patient risk of infection. the manufacturer is advising customers to identify any product from the affected lots/batches within their inventory, segregate the affected product immediately and return it to boston scientific. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 november 2013.