Medical Device Advisories

FDA Advisory No. 2017-329 || Voluntary Recall of AV-Set B DT INF-E Blood Tubing System with DVR No. 8574 (Article No. AP16641)

FDA Advisory No. 2017-329

Voluntary Recall of  AV-Set B DT INF-E Blood Tubing System with DVR No. 8574 (Article No. AP16641)

All are hereby advised by the Food and Drug Administration (FDA) about the voluntary recall of the following batches of AV-Set B DT INF-E Blood Tubing System (see Figures 1 and 2) with DVR No. 8574. The said products were imported and distributed by Fresenius Medical Care Philippines, Inc. with office address at Chino Roces Avenue, Makati City.

Product Name:   AV-Set B DT INF-E Blood Tubing System

Certificate of Registration Number:  DVR-8574

Article No. : AP16641

 

Batch Number

 

Batch Number

 

Batch Number

1

YBC132

18

YGC142

35

YBC144

2

YCC092

19

YGC152

36

YBC153

3

YDC262

20

YBC181

37

YBC181

4

YDC271

21

YCC043A

38

YCC032

5

YDC282

22

YCC122

39

YCC043A

6

YDC301

23

YCC301

40

YCC081

7

YEC013

24

YDC012

41

YCC092

8

YEC031

25

YDC262

42

YCC122

9

YEC053

26

YDC271

43

YDC011

10

YEC294

27

YDC282

44

YDC262

11

YFC012

28

YDC301

45

YDC271

12

YFC023

29

YEC013

46

YDC282

13

YFC091

30

YEC031

47

YDC301

14

YFC103

31

YEC053

48

YEC013

15

YFC113

32

YEC063

49

YEC031

16

YGC102

33

YEC294

50

YEC053

17

YGC131

34

YBC132

*nothing follows*

The above-stated medical device products are being voluntary recalled by Fresenius Medical Care Philippines, Inc. because small clamps located at pre-pump position of T connector and post-pump positions of arterial and venous chamber may not close properly and could in some cases lead to blood leakage during treatment.

Distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product.

Any suspected adverse reaction experienced from the use of the device but not limited to the lot stated above, should be reported immediately to FDA at telephone number (02) 857-1900 local 8301 or email us at This email address is being protected from spambots. You need JavaScript enabled to view it..

Dissemination of the information to all concerned is requested.

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