Important Safety Alerts

Important Safety Alerts

Field Safety Notice: Boston Scientific TWISTERTM Rotatable Polyp Retrieval Device

18 Oct 2011

Medical device supplier, Boston Scientific Corporation, issued an urgent customer notification concerning TWISTERTM Rotatable Polyp Retrieval Device. Below is the list of affected products. All of them are expired on 30 November 2013.

Caption: list of affected products
Product Description Lot / Batch Number
Twister Polyp Retrieval – 13mm (Box 5) H10081204, H10081206
Twister Polyp Retrieval – 13mm (Box 10) H10081215, H10091601, H10091602
Twister Polyp Retrieval – 32mm (Box 1) H10081255, H10081256

There is a labeling issue for TWISTERTM Rotatable Polyp Retrieval Device that the inner pouch listed an incorrect UPN number and basket size. However the outer box UPN and basket size is correct for the device.

According to the local supplier, HK is NOT affected. If you are in possession of the affected products, please contact your supplier for necessary actions.

Back