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U.S. Department of Health and Human Services

Class 2 Device Recall PTA Balloon Dilatation Catheters

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 Class 2 Recall
PTA Balloon Dilatation Catheters
see related information
Date Posted June 12, 2013
Recall Status1 Terminated on October 23, 2013
Recall Number Z-1533-2013
Recall Event ID 65395
Premarket Notification
510(K) Number
K073472 
Product Classification Catheter, Percutaneous - Product Code DQY
Product BARD PERIPHERAL VASCULAR VACCESS® PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess® PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess® PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.
Code Information Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090
Recalling Firm/
Manufacturer
Bard Peripheral Vascular Inc
1625 W 3rd St Ste 109
Tempe, Arizona 85281-2438
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action BARD sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated May 30, 2013 via FedEx overnight with proof of delivery notice to all affected customers. The letter identified the affected product, reason for recall, actions to be taken, and contact information. Customers were instructed to complete the enclosed Recall and Effectivenss Check Form and fax to the attention of Recall Coordinator in Customer Service at 1-800-994-6772.
Quantity in Commerce 415
Distribution US Nationwide Distribution
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = C.R. BARD, INC.
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