託鏗血管攝影導管
回收警訊
（國內無進口受影響產品）
許可證字號：衛署醫器輸字第009437號
產品英文名稱：TORCON NB ANGIOGRAPHIC CATHETER
受影響規格/型號/批號，及其UDI-DI：
| 型號 | 批號 | UDI-DI |
| HNBR5.0-35-100-P-NS-C2 | (國內未進口受影響產品) | 10827002087962 |
| HNBR5.0-35-100-P-NS-DAV | 10827002086996 |
| HNBR5.0-35-100-P-NS-H1 | 10827002084213 |
| HNBR5.0-35-100-P-NS-JB2 | 10827002088099 |
| HNBR5.0-35-100-P-NS-SIM1 | 10827002084718 |
| HNBR5.0-35-100-P-NS-SIM2 | 10827002084220 |
| HNBR5.0-35-100-P-NS-SIM3 | 10827002085975 |
| HNBR5.0-35-100-P-NS-VERT | 10827002114835 |
| HNBR5.0-35-125-P-NS-C2 | 10827002128993 |
| HNBR5.0-35-125-P-NS-VANSCHIE1 | 10827002357331 |
| HNBR5.0-35-125-P-NS-VANSCHIE4 | 10827002357362 |
| HNBR5.0-35-40-P-NS-KMP | 10827002097510 |
| HNBR5.0-35-40-P-NS-VANSCHIE3 | 10827002314082 |
| HNBR5.0-35-65-P-NS-C1 | 10827002084411 |
| HNBR5.0-35-65-P-NS-C2 | 10827002084428 |
| HNBR5.0-35-65-P-NS-C3 | 10827002084435 |
| HNBR5.0-35-65-P-NS-KMP | 10827002114583 |
| HNBR5.0-35-65-P-NS-RC1 | 10827002084695 |
| HNBR5.0-35-65-P-NS-RC2 | 10827002084701 |
| HNBR5.0-35-65-P-NS-RDC | 10827002085968 |
| HNBR5.0-35-65-P-NS-RIM | 10827002084442 |
| HNBR5.0-35-65-P-NS-VANSCHIE1 | 10827002137957 |
| HNBR5.0-35-65-P-NS-VANSCHIE2 | 10827002137940 |
| HNBR5.0-35-65-P-NS-VANSCHIE3 | 10827002137926 |
| HNBR5.0-35-65-P-NS-VANSCHIE4 | 10827002137834 |
| HNBR5.0-35-65-P-NS-VANSCHIE5 | 10827002137933 |
| HNBR5.0-35-80-P-NS-C2 | 10827002112022 |
| HNBR5.0-38-100-P-NS-DAV | 10827002085814 |
| HNBR5.0-38-100-P-NS-JB1 | 10827002085838 |
| HNBR5.0-38-100-P-NS-KMP | 10827002114576 |
| HNBR5.0-38-100-P-NS-SHETTY-050181 | 10827002114750 |
| HNBR5.0-38-100-P-NS-SIM1 | 10827002085845 |
| HNBR5.0-38-100-P-NS-SIM2 | 10827002084206 |
| HNBR5.0-38-100-P-NS-VERT | 10827002114842 |
| HNBR5.0-38-125-P-NS-H1 | 10827002113784 |
| HNBR5.0-38-125-P-NS-VERT | 10827002121703 |
| HNBR5.0-38-125-P-NS-VTK | 10827002116426 |
| HNBR5.0-38-40-P-NS-KMP | 10827002095486 |
| HNBR5.0-38-65-P-NS-C2 | 10827002084473 |
| HNBR5.0-38-65-P-NS-H1 | 10827002113951 |
| HNBR5.0-38-65-P-NS-KMP | 10827002094694 |
| HNBR5.0-38-65-P-NS-MPA | 10827002111957 |
| HNBR5.0-38-65-P-NS-RDC | 10827002085784 |
| HNBR5.0-38-65-P-NS-RIM | 10827002100821 |
| HNBR5.0-38-65-P-NS-SHK1.0 | 10827002114767 |
| HNBR5.0-38-65-P-NS-SIM1 | 10827002086774 |
| HNBR5.0-38-65-P-NS-SIM2 | 10827002086255 |
| HNBR5.0-38-65-P-NS-SIM3 | 10827002088495 |
| HNBR5.0-38-65-P-NS-VS1 | 10827002114866 |
| HNBR5.0-38-80-P-NS-C1 | 10827002112039 |
| HNBR5.0-38-80-P-NS-CHG2.5 | 10827002114309 |
| HNBR5.0-38-80-P-NS-CHG3 | 10827002135731 |
| HNBR5.0-38-80-P-NS-MIK | 10827002093123 |
| HNBR5.0-38-80-P-NS-MPB | 10827002114699 |
| HNBR5.0-38-80-P-NS-VS1 | 10827002111896 |
| HNBR5.0-38-80-P-NS-VS2 | 10827002111902 |
發布對象：醫療專業人員
警訊說明：(回收/矯正原因描述)
原廠透過四起客戶投訴發現，特定批號產品中的導管出現尖端分離。進一步調查顯示，該問題是由於某位特定操作員的製程偏差造成的；因而回收含有該操作員生產零件的相關產品。
國內矯正措施：
經查，台灣曲克股份有限公司未進口警訊所述受影響產品。
廠商聯繫資訊：
公司名稱：台灣曲克股份有限公司
聯絡電話：02-66283542
聯絡人電子郵件：stacey.chang@cookmedical.com
相關警訊來源(網址)：
美國FDA：https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=213776