Medical device recalls Moderate risk

Bard Peripheral Vascular Inc recalls Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

Recall date
March 23, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1413-2015
FDA classification
Class II
Brand / firm
Bard Peripheral Vascular Inc
Sold / distributed
Worldwide Distribution - US Distribution including Puerto Rico and the countries of : Austria, Belgium, Germany, France, Greece, Iran, Ireland, Israel, Martinique, Netherlands, Portugal, Russia, Slovenia, South Africa, Spain, United Arab Emirates (UAE), United Kingdom, Canada, Korea, Taiwan, Singap…

Why it was recalled

Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

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