"曲克" 皇家血管攝影導管、"曲克"託鏗血管攝影導管、
"曲克"史利普血管攝影導管、"曲克"史利普導引導管
回收警訊
許可證字號:衛署醫器輸字第010905、009437、017394、019553號
產品英文名稱:
"COOK" ROYAL FLUSH PLUS ANGIOGRAPHIC CATHETER
TORCON NB ANGIOGRAPHIC CATHETER
"COOK"SLIP-CATH ANGIOGRAPHIC SELECTIVE CATHETERS
"COOK" Slip-Cath guiding Catheters
受影響規格/型號/批號:
RPN No. |
Lot Number |
RPN No. |
Lot Number |
HNBR5.0-35-90-P-NS-RUC |
4377470 |
HNR4.0-35-70-P-10S-0 |
4468146 |
HNBR5.0-35-90-P-NS-RUC |
4378752 |
HNR4.0-35-70-P-10S-0 |
4503747 |
HNBR5.0-35-90-P-NS-RUC |
4492858 |
HNR4.0-35-70-P-10S-PIG |
4468817 |
HNBR5.0-35-90-P-NS-RUC |
4550026 |
HNR4.0-35-90-P-10S-PIG |
4424057 |
HNBR5.0-35-90-P-NS-RUC |
4553422 |
HNR4.0-35-90-P-10S-PIG |
4516202 |
HNBR5.0-35-90-P-NS-RUC |
4633779 |
HNR4.0-35-90-P-10S-PIG |
4612538 |
HNBR5.0-35-90-P-NS-RUC |
4638371 |
HNR4.0-35-90-P-10S-PIG |
4686748 |
HNBR5.0-35-90-P-NS-RUC |
4655004 |
HNR4.0-35-90-P-10S-PIG |
4783765 |
HNBR5.0-35-90-P-NS-RUC |
4680959 |
HNR4.0-35-90-P-10S-PIG |
4920501 |
HNBR5.0-35-90-P-NS-RUC |
4698901 |
HNR4.0-35-90-P-10S-PIG |
5006207 |
HNBR5.0-35-90-P-NS-RUC |
4708236 |
HNR4.0-35-90-P-8S-VCF |
F4282268 |
HNR4.0-35-100-P-10S-PIG |
4262141 |
HNR4.0-35-90-P-8S-VCF |
F4296981 |
HNR4.0-35-100-P-10S-PIG |
4598587 |
HNR4.0-35-90-P-8S-VCF |
F4310288 |
HNR4.0-35-100-P-10S-PIG |
4288143 |
HNR4.0-35-90-P-8S-VCF |
F4345321 |
HNR4.0-35-100-P-10S-PIG |
4317223 |
HNR4.0-35-90-P-8S-VCF |
F4377850 |
HNR4.0-35-100-P-10S-PIG |
4364547 |
HNR4.0-35-90-P-8S-VCF |
F4616393 |
HNR4.0-35-100-P-10S-PIG |
4454709 |
HNR4.0-35-90-P-8S-VCF |
F4640510 |
HNR4.0-35-100-P-10S-PIG |
4495343 |
HNR4.0-35-90-P-8S-VCF |
F4656924 |
HNR4.0-35-100-P-10S-PIG |
4565332 |
HNR4.0-35-90-P-8S-VCF |
F4681897 |
HNR4.0-35-100-P-10S-PIG |
4649676 |
HNR4.0-35-90-P-8S-VCF |
F4712615 |
HNR4.0-35-100-ST-6S-PED |
F4320156 |
HNR4.0-35-90-P-8S-VCF |
F4732472 |
HNR4.0-35-100-ST-6S-PED |
F4492821 |
HNR4.0-35-90-P-8S-VCF |
F4759862 |
HNR4.0-35-100-ST-6S-PED |
F4669177 |
HNR4.0-35-90-P-8S-VCF |
F4894865 |
發布對象:醫療從業人員/醫療器材專業人員
警訊說明
曲克原廠發現:因特定原料有瑕疵,造成產品不良率上升,導致使用某些特定批號之血管攝影導管時,發生導管尖端脫落及/或分離之呈報事件,對病患產生潛在風險。因此原廠針對受影響批號之產品啟動自願性回收。
國內矯正措施
經查,本次受影響之許可證產品僅有"曲克"皇家血管攝影導管 (衛署醫器輸字第010905號)及"曲克"託鏗血管攝影導管 (衛署醫器輸字第009437號),受影響醫療院所約20間。曲克公司已於104年7月8日針對受影響批號之產品進行客戶通知與回收作業,預計於104年8月8日前完成回收。
另有關"曲克"史利普血管攝影導管 (衛署醫器輸字第017394號) 及"曲克"史利普導引導管(衛署醫器輸字第019553號) 2張許可證產品,因其受影響批號未進口至國內,故無需進行回收作業。
廠商聯絡資訊:台灣曲克股份有限公司
附件(提供下載) :警訊摘譯
相關警訊連結(網址) :PMDA
http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-6386
http://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfmaude/detail.cfm?mdrfoi__id=2612919