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U.S. Department of Health and Human Services

Class 2 Device Recall Viatrac 14 Plus Peripheral Dilatation Catheter

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 Class 2 Recall
Viatrac 14 Plus Peripheral Dilatation Catheter
see related information
Date Posted March 22, 2010
Recall Status1 Terminated on March 30, 2012
Recall Number Z-1178-2010
Recall Event ID 53474
Premarket Notification
510(K) Number
Product Classification Catheter, Angioplasty, Peripheral, Transluminal - Product Code LIT
Product Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Code Information Lot Number: 8121251.
Recalling Firm/
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula, California 92591-4630
Manufacturer Reason
for Recall
Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.
Action Abbott Vascular issued an "Urgent Device Recall" notification dated May 7, 2009. Consignees were informed of the affected product and instructed to work with local sales representatives in identifying any unused devices and arrange for return to the firm. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.
Quantity in Commerce 26
Distribution Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = LIT and Original Applicant = ABBOTT VASCULAR-VASCULAR SOLUTIONS