ENDOPATH Probe Plus ll Shafts 의 안전성 경고

Safety alert

2013-04-26

2013-04-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426b.html

Medical device safety alert: ethicon endopath probe plus ll shafts medical device manufacturer, ethicon, has issued a field safety notice concerning endopath probe plus ll shafts. the affected code numbers are eps01-eps08 (with expiration dates from september 2015 through and including march 2018) and eps10-eps13 (with expiration dates from april 2013 through and including march 2018). the manufacturer is initiating a voluntary recall for endopath probe plus ll shafts because the possibility that a tear in the tyvek packaging may compromise the sterility of the device such that we could no longer assure the stated sterility levels are met for our product. the endopath probe plus ll shaft is sold and labeled as “sterile”. this voluntary recall does not apply to the endopath probe plus ii handles. product recall is on-going. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.