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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description 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.
Recall Number Z-1533-2013
Classification Class II
Code Info Product Codes and Lot Numbers, respectively: VA8084R, 93JW0056 VA8084, 937W0090
Product Distributed Qty 415
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.

Event Detail

Event Id 65395
Product Type Devices
Status Ongoing
Recalling Firm Bard Peripheral Vascular Inc
City Tempe
State AZ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution