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“亞培”恩希快克冠狀動脈氣球擴張導管 回收警訊
| 發布日期:2017-05-10 | 更新日期:2018-03-26 發布單位:醫療器材及化粧品組

“亞培”恩希快克冠狀動脈氣球擴張導管

回收警訊

許可證字號: 衛署醫器輸字第023212

產品英文名稱:“Abbott NC TREK RX Coronary Dilatation Catheter

受影響規格/型號/批號:

型號

產品型號敘述

批號

進口數量

1012448-08

NC TREK RX 2.75 X 8MM BDC

60419G1

4

1012448-08

NC TREK RX 2.75 X 8MM BDC

60420G1

6

1012448-08

NC TREK RX 2.75 X 8MM BDC

60603G1

11

1012448-08

NC TREK RX 2.75 X 8MM BDC

60906G1

5

1012448-08

NC TREK RX 2.75 X 8MM BDC

61121G1

9

1012448-12

NC TREK RX 2.75 X 12MM BDC

60607G1

9

1012448-12

NC TREK RX 2.75 X 12MM BDC

60705G1

6

1012448-12

NC TREK RX 2.75 X 12MM BDC

60804G1

3

1012448-12

NC TREK RX 2.75 X 12MM BDC

60818G1

5

1012448-12

NC TREK RX 2.75 X 12MM BDC

60921G1

20

1012448-12

NC TREK RX 2.75 X 12MM BDC

60921G2

17

1012448-12

NC TREK RX 2.75 X 12MM BDC

61108G1

30

1012448-12

NC TREK RX 2.75 X 12MM BDC

61111G1

11

1012448-12

NC TREK RX 2.75 X 12MM BDC

61128G1

4

1012448-12

NC TREK RX 2.75 X 12MM BDC

61128G2

10

1012448-12

NC TREK RX 2.75 X 12MM BDC

61218G1

31

1012448-15

NC TREK RX 2.75 X 15MM BDC

60616G1

2

1012448-15

NC TREK RX 2.75 X 15MM BDC

60721G1

11

1012448-15

NC TREK RX 2.75 X 15MM BDC

60809G1

2

1012448-15

NC TREK RX 2.75 X 15MM BDC

60912G1

11

1012448-15

NC TREK RX 2.75 X 15MM BDC

61028G1

68

1012448-15

NC TREK RX 2.75 X 15MM BDC

61206G1

41

1012448-20

NC TREK RX 2.75 X 20MM BDC

60310G1

1

1012448-20

NC TREK RX 2.75 X 20MM BDC

60421G1

4

1012448-20

NC TREK RX 2.75 X 20MM BDC

60527G1

7

1012448-20

NC TREK RX 2.75 X 20MM BDC

60716G1

23

1012448-20

NC TREK RX 2.75 X 20MM BDC

60819G1

30

1012448-20

NC TREK RX 2.75 X 20MM BDC

61024G2

34

1012449-08

NC TREK RX 3.00 X 8MM BDC

60502G1

2

1012449-08

NC TREK RX 3.00 X 8MM BDC

60502G2

17

1012449-08

NC TREK RX 3.00 X 8MM BDC

60525G1

16

1012449-08

NC TREK RX 3.00 X 8MM BDC

60705G1

11

1012449-08

NC TREK RX 3.00 X 8MM BDC

60801G1

10

1012449-08

NC TREK RX 3.00 X 8MM BDC

60916G1

10

1012449-08

NC TREK RX 3.00 X 8MM BDC

61018G1

20

1012449-08

NC TREK RX 3.00 X 8MM BDC

61121G1

1

1012449-08

NC TREK RX 3.00 X 8MM BDC

61121G2

3

1012449-12

NC TREK RX 3.00 X 12MM BDC

60623G1

4

1012449-12

NC TREK RX 3.00 X 12MM BDC

60805G1

14

1012449-12

NC TREK RX 3.00 X 12MM BDC

60809G1

4

1012449-12

NC TREK RX 3.00 X 12MM BDC

60812G1

3

1012449-12

NC TREK RX 3.00 X 12MM BDC

60824G1

3

1012449-12

NC TREK RX 3.00 X 12MM BDC

60926G1

26

1012449-12

NC TREK RX 3.00 X 12MM BDC

61019G1

10

1012449-12

NC TREK RX 3.00 X 12MM BDC

61020G1

54

1012449-12

NC TREK RX 3.00 X 12MM BDC

61121G1

10

1012449-12

NC TREK RX 3.00 X 12MM BDC

61122G1

13

1012449-12

NC TREK RX 3.00 X 12MM BDC

61123G1

16

1012449-12

NC TREK RX 3.00 X 12MM BDC

61201G1

28

1012449-12

NC TREK RX 3.00 X 12MM BDC

61214G2

5

1012449-12

NC TREK RX 3.00 X 12MM BDC

61216G2

32

1012449-15

NC TREK RX 3.00 X 15MM BDC

60609G1

13

1012449-15

NC TREK RX 3.00 X 15MM BDC

60621G1

6

1012449-15

NC TREK RX 3.00 X 15MM BDC

60718G1

7

1012449-15

NC TREK RX 3.00 X 15MM BDC

60809G1

17

1012449-15

NC TREK RX 3.00 X 15MM BDC

60816G1

5

1012449-15

NC TREK RX 3.00 X 15MM BDC

60906G1

67

1012449-15

NC TREK RX 3.00 X 15MM BDC

60926G1

18

1012449-15

NC TREK RX 3.00 X 15MM BDC

61104G1

41

1012449-15

NC TREK RX 3.00 X 15MM BDC

61107G1

34

1012449-15

NC TREK RX 3.00 X 15MM BDC

61122G1

14

1012449-15

NC TREK RX 3.00 X 15MM BDC

61123G1

17

1012449-15

NC TREK RX 3.00 X 15MM BDC

61128G1

8

1012449-15

NC TREK RX 3.00 X 15MM BDC

61130G1

10

1012449-15

NC TREK RX 3.00 X 15MM BDC

61202G1

9

1012449-20

NC TREK RX 3.00 X 20MM BDC

60226G1

6

1012449-20

NC TREK RX 3.00 X 20MM BDC

60516G1

36

1012449-20

NC TREK RX 3.00 X 20MM BDC

60519G1

27

1012449-20

NC TREK RX 3.00 X 20MM BDC

60721G1

11

1012449-20

NC TREK RX 3.00 X 20MM BDC

60805G1

24

1012449-20

NC TREK RX 3.00 X 20MM BDC

60824G1

26

1012449-20

NC TREK RX 3.00 X 20MM BDC

60907G1

31

1012449-20

NC TREK RX 3.00 X 20MM BDC

61004G1

29

1012449-20

NC TREK RX 3.00 X 20MM BDC

61116G1

56

1012449-20

NC TREK RX 3.00 X 20MM BDC

61128G1

12

1012450-08

NC TREK RX 3.25 X 8MM BDC

60530G1

15

1012450-08

NC TREK RX 3.25 X 8MM BDC

60803G1

12

1012450-08

NC TREK RX 3.25 X 8MM BDC

61014G1

4

1012450-08

NC TREK RX 3.25 X 8MM BDC

61206G1

2

1012450-12

NC TREK RX 3.25 X 12MM BDC

60212G1

12

1012450-12

NC TREK RX 3.25 X 12MM BDC

60412G1

5

1012450-12

NC TREK RX 3.25 X 12MM BDC

60414G1

6

1012450-12

NC TREK RX 3.25 X 12MM BDC

60528G1

12

1012450-12

NC TREK RX 3.25 X 12MM BDC

60623G1

6

1012450-12

NC TREK RX 3.25 X 12MM BDC

60831G1

2

1012450-12

NC TREK RX 3.25 X 12MM BDC

60921G1

23

1012450-12

NC TREK RX 3.25 X 12MM BDC

61104G1

2

1012450-12

NC TREK RX 3.25 X 12MM BDC

61207G1

3

1012450-12

NC TREK RX 3.25 X 12MM BDC

61209G1

5

1012450-15

NC TREK RX 3.25 X 15MM BDC

60414G2

3

1012450-15

NC TREK RX 3.25 X 15MM BDC

60613G1

8

1012450-15

NC TREK RX 3.25 X 15MM BDC

60718G1

9

1012450-15

NC TREK RX 3.25 X 15MM BDC

60810G1

10

1012450-15

NC TREK RX 3.25 X 15MM BDC

60901G1

12

1012450-15

NC TREK RX 3.25 X 15MM BDC

60922G1

19

1012450-15

NC TREK RX 3.25 X 15MM BDC

61128G1

5

1012450-15

NC TREK RX 3.25 X 15MM BDC

61130G1

14

1012450-20

NC TREK RX 3.25 X 20MM BDC

60429G1

4

1012450-20

NC TREK RX 3.25 X 20MM BDC

60613G1

8

1012450-20

NC TREK RX 3.25 X 20MM BDC

60804G1

5

1012450-20

NC TREK RX 3.25 X 20MM BDC

60929G1

17

1012451-08

NC TREK RX 3.50 X 8MM BDC

60526G1

9

1012451-08

NC TREK RX 3.50 X 8MM BDC

60531G1

10

1012451-08

NC TREK RX 3.50 X 8MM BDC

60623G1

9

1012451-08

NC TREK RX 3.50 X 8MM BDC

60713G1

4

1012451-08

NC TREK RX 3.50 X 8MM BDC

60805G1

1

1012451-08

NC TREK RX 3.50 X 8MM BDC

60819G1

9

1012451-08

NC TREK RX 3.50 X 8MM BDC

60929G1

15

1012451-08

NC TREK RX 3.50 X 8MM BDC

61104G1

11

1012451-08

NC TREK RX 3.50 X 8MM BDC

61204G1

3

1012451-08

NC TREK RX 3.50 X 8MM BDC

61206G1

9

1012451-08

NC TREK RX 3.50 X 8MM BDC

61207G1

6

1012451-12

NC TREK RX 3.50 X 12MM BDC

60527G2

10

1012451-12

NC TREK RX 3.50 X 12MM BDC

60601G1

17

1012451-12

NC TREK RX 3.50 X 12MM BDC

60629G1

21

1012451-12

NC TREK RX 3.50 X 12MM BDC

60805G1

22

1012451-12

NC TREK RX 3.50 X 12MM BDC

60818G1

8

1012451-12

NC TREK RX 3.50 X 12MM BDC

60829G1

8

1012451-12

NC TREK RX 3.50 X 12MM BDC

60907G1

7

1012451-12

NC TREK RX 3.50 X 12MM BDC

60922G1

32

1012451-12

NC TREK RX 3.50 X 12MM BDC

61003G1

6

1012451-12

NC TREK RX 3.50 X 12MM BDC

61108G1

45

1012451-12

NC TREK RX 3.50 X 12MM BDC

61114G1

4

1012451-12

NC TREK RX 3.50 X 12MM BDC

61122G1

1

1012451-12

NC TREK RX 3.50 X 12MM BDC

61123G1

13

1012451-12

NC TREK RX 3.50 X 12MM BDC

61130G1

20

1012451-12

NC TREK RX 3.50 X 12MM BDC

61213G1

10

1012451-15

NC TREK RX 3.50 X 15MM BDC

60408G1

1

1012451-15

NC TREK RX 3.50 X 15MM BDC

60607G1

9

1012451-15

NC TREK RX 3.50 X 15MM BDC

60628G1

10

1012451-15

NC TREK RX 3.50 X 15MM BDC

60727G1

12

1012451-15

NC TREK RX 3.50 X 15MM BDC

60801G1

2

1012451-15

NC TREK RX 3.50 X 15MM BDC

60826G2

51

1012451-15

NC TREK RX 3.50 X 15MM BDC

60909G1

37

1012451-15

NC TREK RX 3.50 X 15MM BDC

60909G2

10

1012451-15

NC TREK RX 3.50 X 15MM BDC

60913G1

16

1012451-15

NC TREK RX 3.50 X 15MM BDC

61024G1

23

1012451-15

NC TREK RX 3.50 X 15MM BDC

61101G1

1

1012451-15

NC TREK RX 3.50 X 15MM BDC

61115G1

43

1012451-15

NC TREK RX 3.50 X 15MM BDC

61123G1

9

1012451-15

NC TREK RX 3.50 X 15MM BDC

61123G2

10

1012451-15

NC TREK RX 3.50 X 15MM BDC

61202G1

25

1012451-15

NC TREK RX 3.50 X 15MM BDC

61204G1

4

1012451-15

NC TREK RX 3.50 X 15MM BDC

61214G1

33

1012451-20

NC TREK RX 3.50 X 20MM BDC

60419G1

2

1012451-20

NC TREK RX 3.50 X 20MM BDC

60419G2

15

1012451-20

NC TREK RX 3.50 X 20MM BDC

60519G1

32

1012451-20

NC TREK RX 3.50 X 20MM BDC

60603G1

20

1012451-20

NC TREK RX 3.50 X 20MM BDC

60824G1

11

1012451-20

NC TREK RX 3.50 X 20MM BDC

60901G1

36

1012451-20

NC TREK RX 3.50 X 20MM BDC

60927G1

14

1012451-20

NC TREK RX 3.50 X 20MM BDC

61115G1

16

1012451-20

NC TREK RX 3.50 X 20MM BDC

61201G1

31

1012452-08

NC TREK RX 3.75 X 8MM BDC

50319G1

2

1012452-08

NC TREK RX 3.75 X 8MM BDC

50513G1

7

1012452-08

NC TREK RX 3.75 X 8MM BDC

51022G1

4

1012452-08

NC TREK RX 3.75 X 8MM BDC

60112G1

5

1012452-08

NC TREK RX 3.75 X 8MM BDC

60603G1

2

1012452-08

NC TREK RX 3.75 X 8MM BDC

60810G1

2

1012452-08

NC TREK RX 3.75 X 8MM BDC

60921G1

1

1012452-08

NC TREK RX 3.75 X 8MM BDC

61216G1

4

1012452-12

NC TREK RX 3.75 X 12MM BDC

50109G1

3

1012452-12

NC TREK RX 3.75 X 12MM BDC

50306G1

2

1012452-12

NC TREK RX 3.75 X 12MM BDC

50330G1

1

1012452-12

NC TREK RX 3.75 X 12MM BDC

50817G1

17

1012452-12

NC TREK RX 3.75 X 12MM BDC

50928G1

9

1012452-12

NC TREK RX 3.75 X 12MM BDC

51023G1

4

1012452-12

NC TREK RX 3.75 X 12MM BDC

60311G1

3

1012452-12

NC TREK RX 3.75 X 12MM BDC

60712G1

6

1012452-12

NC TREK RX 3.75 X 12MM BDC

61102G1

10

1012452-12

NC TREK RX 3.75 X 12MM BDC

61122G1

6

1012452-15

NC TREK RX 3.75 X 15MM BDC

50105G1

7

1012452-15

NC TREK RX 3.75 X 15MM BDC

50316G1

2

1012452-15

NC TREK RX 3.75 X 15MM BDC

50319G1

17

1012452-15

NC TREK RX 3.75 X 15MM BDC

50420G1

7

1012452-15

NC TREK RX 3.75 X 15MM BDC

50609G1

4

1012452-15

NC TREK RX 3.75 X 15MM BDC

50929G1

13

1012452-15

NC TREK RX 3.75 X 15MM BDC

60505G1

4

1012452-15

NC TREK RX 3.75 X 15MM BDC

60826G1

8

1012452-15

NC TREK RX 3.75 X 15MM BDC

61115G1

4

1012452-15

NC TREK RX 3.75 X 15MM BDC

61128G1

8

1012452-15

NC TREK RX 3.75 X 15MM BDC

61208G1

6

1012452-20

NC TREK RX 3.75 X 20MM BDC

50106G1

7

1012452-20

NC TREK RX 3.75 X 20MM BDC

50603G1

4

1012452-20

NC TREK RX 3.75 X 20MM BDC

51110G1

12

1012452-20

NC TREK RX 3.75 X 20MM BDC

60412G1

6

1012452-20

NC TREK RX 3.75 X 20MM BDC

60607G1

4

1012452-20

NC TREK RX 3.75 X 20MM BDC

61018G1

4

1012453-08

NC TREK RX 4.00 X 8MM BDC

60405G1

1

1012453-08

NC TREK RX 4.00 X 8MM BDC

60413G1

9

1012453-08

NC TREK RX 4.00 X 8MM BDC

60413G2

2

1012453-08

NC TREK RX 4.00 X 8MM BDC

60425G1

9

1012453-08

NC TREK RX 4.00 X 8MM BDC

60425G2

6

1012453-08

NC TREK RX 4.00 X 8MM BDC

60621G1

16

1012453-08

NC TREK RX 4.00 X 8MM BDC

60720G1

2

1012453-08

NC TREK RX 4.00 X 8MM BDC

60729G1

1

1012453-08

NC TREK RX 4.00 X 8MM BDC

60819G1

7

1012453-08

NC TREK RX 4.00 X 8MM BDC

61026G1

17

1012453-08

NC TREK RX 4.00 X 8MM BDC

61130G1

10

1012453-08

NC TREK RX 4.00 X 8MM BDC

61204G1

16

1012453-12

NC TREK RX 4.00 X 12MM BDC

60503G1

4

1012453-12

NC TREK RX 4.00 X 12MM BDC

60503G2

2

1012453-12

NC TREK RX 4.00 X 12MM BDC

60621G1

3

1012453-12

NC TREK RX 4.00 X 12MM BDC

60705G1

19

1012453-12

NC TREK RX 4.00 X 12MM BDC

60722G1

13

1012453-12

NC TREK RX 4.00 X 12MM BDC

60810G1

10

1012453-12

NC TREK RX 4.00 X 12MM BDC

60907G1

16

1012453-12

NC TREK RX 4.00 X 12MM BDC

61004G1

24

1012453-12

NC TREK RX 4.00 X 12MM BDC

61012G1

20

1012453-12

NC TREK RX 4.00 X 12MM BDC

61218G1

5

1012453-15

NC TREK RX 4.00 X 15MM BDC

60428G1

7

1012453-15

NC TREK RX 4.00 X 15MM BDC

60613G1

3

1012453-15

NC TREK RX 4.00 X 15MM BDC

60617G1

6

1012453-15

NC TREK RX 4.00 X 15MM BDC

60721G1

6

1012453-15

NC TREK RX 4.00 X 15MM BDC

60819G1

13

1012453-15

NC TREK RX 4.00 X 15MM BDC

61026G1

15

1012453-20

NC TREK RX 4.00 X 20MM BDC

60505G1

1

1012453-20

NC TREK RX 4.00 X 20MM BDC

60623G1

11

1012453-20

NC TREK RX 4.00 X 20MM BDC

60810G1

10

1012453-20

NC TREK RX 4.00 X 20MM BDC

60926G1

16

1012453-20

NC TREK RX 4.00 X 20MM BDC

61122G1

14

總計進口數量

2,776

發布對象:醫療從業人員/醫療器材專業人員

警訊說明:(回收/矯正原因描述)

“亞培”恩希快克冠狀動脈氣球擴張導管的特定批號產品,有可能因不易移除氣球保護鞘而導致氣球無法充氣或洩氣。此種狀況可能產生下列風險:氣泡栓塞、額外處置、血栓及心肌梗塞。根據全球案例,目前其中一例國外通報案例中,原手術所使用的氣球擴張導管因無法洩壓,而導致病人因術後多項併發症死亡。

國內矯正措施:

經查,國內進口之受影響產品數量共2,776支,美商亞培股份有限公司台灣分公司已於106322日起通知使用單位並提供建議事項。前述回收行動預計於106531日完成。

廠商聯絡資訊

公司名稱:美商亞培股份有限公司台灣分公司

聯絡電話:02-21836813

聯絡人電子郵件:christie.ho@abbott.com

相關警訊來源(網址) :廠商提供紙本資料