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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Recall Number Z-0134-2014
Classification Class II
Code Info Lot number 59388992 expiry 1/1/16
Product Distributed Qty 80 units
Reason For Recall Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.

Event Detail

Event Id 66112
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Draper
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.
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