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Bard Peripheral Vascular Inc recalls Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usag
Recalled October 14, 2020 · FDA recall Z-0080-2021 · Bard Peripheral Vascular
Hazard
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure. · FDA Class II
Units
281 units
Sold at
Worldwide distribution - US Nationwide distribution including in the states of GA, AZ, MD, CA, VA, AR, TX, SD, NC, MO, WI, CO, FL, PA and the country of Taiwan.
Description
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
Product
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: 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.
Manufacturer(s)
Bard Peripheral Vascular Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →