Medical Device Advisories

FDA Advisory No. 2017-184 || VOLUNTARY RECALL NC TREX RX CORONARY DILATATION CATHETER, WITH MDR-00260

FDA Advisory No. 2017-184

VOLUNTARY RECALL NC TREX RX CORONARY DILATATION CATHETER, WITH MDR-00260

All are hereby advised by the Food and Drug Administration (FDA) about the voluntary recall of the following NC Trex Rx coronary dilatation catheter with MDR-00260 product code 1012448-06,1012448-08,1012448-12,1012448-20, 1012449-08, 1012449-12, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 101250-15, 101251-12, 101251-15, 1012452-08, 1012452-12, 1012453-12, 1012453-15, 1012453-20 distributed by Getz Bros. Philippines, Inc. 5th Floor Ortigas Bldg., Ortigas Avenue, Pasig City:

PRODUCT CODE:

MDR-00260

DESCRIPTION:

NC Trex Rx Coronary Dilatation Catheter (2. 75 Mm, 3.00 Mm, 3.25 Mm, 3.50 Mm, 3.75 Mm & 4.00 Mm)

Product Code

Lot Numbers

Product Code

        Lot Numbers

 

 

 

  

       1012448-06

 

 

 

60414G1

60721G1

 

 

 

 

1012448-20

60310G1

60421G1

60421G2

60527G1

60716G1

60819G1

60024G2

 

 

 

 

1012448-08

 

 

 

 

 

 

1012551-25

 

 

60208G1

60419G1

60420G1

60603G1

60906G1

61121G1

61121G2

 

 

60809G1

 

 

 

 

 

 

 

1012449-08

60317G1

60318G1

60412G1

60419G1

60502G1

60502G2

60525G1

60705G1

60801G1

60809G1

60826G1

60916G1

61121G1

61121G2

 

 

 

 

1012448-12

 

 

 

 

 

 

 

 

        1012448-12

 

 

 

 

 

 

 

 

 

 

 

 

         1012449-20

 

 

 

 

 

 

 

 

 

 

1012453-20

60225G1

60229G1

60318G1

60318G2

60429G1

60429G2

60607G1

 

60705G1

60804G1

60818G1

60921G1

60921G2

61108G1

61111G1

61128G1

61128G2

61218G1

 

60126G1

60223G1

60225G1

60226G1

60323G1

60331G2

60516G1

60519G1

60721G1

60805G1

60824G1

60907G1

61004G1

61116G1

61130G1

 

60209G1

60226G1

60505G1

60623G1

61122G1

 

 

 

1012449-12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1012449-12

60218G1

60303G1

60330G1

60330G2

60406G1

60406G2

60406G3

60406G4

60408G1

60413G1

60413G2

60425G1

60429G1

60511G1

60512G1

60531G1

60607G1

60623G1

60713G1

60721G1

60804G1

60805G1

60809G1

60816G1

60824G1

60926G1

60929G1

61012G1

61019G1

61019G2

61020G1

61115G1

61121G1

61122G1

61123G1

61123G2

61201G1

61208G1

61214G1

61214G2

61216G1

61216G2

 

  

1012451-12

 

 

 

 

 

1012452-08

 

 

 

 

 

 

1012450-15

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1012451-15

 

60205G1

60214G1

60502G1

61108G1

61213G1

 

60810G1

60921G1

61007G1

61216G1

 

60315G1

61130G1

60718G1

60901G1

60922G1

61128G1

60414G2

60505G1

60331G1

60224G1

 

 

60210G1

60224G1

60331G1

60505G1

60408G2

60913G1

60909G2

60828G2

60826G1

60727G1

60701G1

60607G1

60603G1

 

 

1012449-25

 

 

 

1012450-06

 

 

 

 

1012450-08

 

 

 

 

1012452-12

 

 

 

1012453-12

 

 

 

 

 

 

 

 

 

1012453-15

 

60405G1

60412G1

60805G1

 

 

60610G1

61101G1

 

60530G1

60803G1

61014G1

61206G1

 

50109G1

50316G1

50210G1

 

60705G1

60810G1

60502G1

60621G1

 

 

60301G1

61111G1

61026G1

61121G1

60822G1

60428G1

60819G1

60331G1

60721G1

60909G1

60613G1

60303G1

60617G1

The cited product are being voluntarily recalled by Getz Bros. Philippines, Inc. because Abbot Vascular has initiated a voluntary field action regarding specific lots of the NC Trex Rx Coronary Dilatation Catheter, NC Traveller Rx Coronary Dilatation Catheter, and NC Tenku Rx PTCA Ballon Catheter.

Production from the identified lots may exhibit difficult in removing the protective ballon sheath which can result in issues with inflating or deflating the ballon. The worldwide frequency of tight sheath removal, inflation and deflation and reported event is 0.12%. Potential risks associated with ballon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardiac infarction. In one reported case, failure to deflate the ballon necessitated surgery, leading to multiple post-operative complication and death.

Distributors, retailers, hospitals that have any of the stated medical device product are instructed to discontinue further distribution, sale and use. All consumers are likewise advised not to purchase or use the affected product lots.

Any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to FDA at telephone no. (02) 857-1900 loc. 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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