Zurpaz Steerable Sheath 8.5F Asymmetric and Symmetric Curves 의 안전성 경고

Safety alert

2017-06-05

2017-06-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170605a.html

Medical device safety alert: creganna tactx medical zurpaz steerable sheath 8.5f asymmetric and symmetric curves boston scientific has issued a medical device safety alert concerning zurpaz steerable sheath, 8.5f asymmetric and symmetric curves, manufactured by creganna tactx medical. the affected products are identified as follows: 8.5f asymmetric curve (us model) material number: m004usmca85200; lot number: 364951; expiration date: 13-dec-2018 8.5f symmetric curve (us model) material number: m004usmc85100; lot number: 383271; expiration date: 3-jan-2019 boston scientific, a distributor of the zurpaz steerable sheath, became aware from the manufacturer, creganna medical (also doing business as creganna tactx medical), that a blister near the pouch seal may result in a compromised sterile barrier. pouch blistering might not be obvious to the user. if it is identified, the device can be readily exchanged resulting in an insignificant prolongation in procedure. if the sterile barrier was compromised and the device was used, the most severe expected harm is a potential infection; however no reports of patient harm have been received. further distribution or use of the affected product should cease immediately. affected users should segregate the product immediately and return it to boston scientific. product recall is on-going. 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 5 june 2017.