Vascu-Guard Peripheral Vascular Patch 의 안전성 경고

Safety alert

2015-06-04

2015-06-04

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150604a.html

Medical device safety alert: baxter vascu-guard peripheral vascular patch the united states food and drug administration (fda) has issued medical device safety alerts concerning vascu-guard peripheral vascular patch. the affected devices are identified as follow:- model numbers: 1504026 vascu-guard ts 1x6cm 1504028 vascu-guard ts 0.8x8cm 1504030 vascu-guard ts 1x10cm 1504032 vascu-guard ts 2x9cm the manufacturer received customer complaints of difficulty in distinguishing the smooth from rough surface of the vascu-guard patch as described in the instructions for use. this is due to a deviation in the surface texture of the vascular patch in a new packaging configuration. the manufacturer is recalling above product codes of its vascu-guard peripheral vascular patch. users can still order this product presented in a plastic jar filled with sterile water and 1% propylene oxide, such configuration is unaffected by this recall. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm449592.Htm http://www.Fda.Gov/safety/recalls/ucm449477.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 june 2015.