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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 QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona­ pyrogenic in a sealed, peel-type pouch.
Recall Number Z-1542-2013
Classification Class II
Code Info Model QD22: Lot No. 59049758, 59054488, 59067502, 59074170, 59081626, 59083736, 59091652, 59094887, 59114755, 59117451, 59134508, 59149651, 59154310, 59178579, 59201243, 59212118, 59222657, 59233636, 59233637, 59246684, 59246701, 59255899, 59255900, 59269439, 59284780, 59287725, 59296462, 59299605, 59315339, 59320575, 59334652, 59356129, 59360072, 59365198, 59365199, 59374009, 59384309, 59390552, 59394166, 59394167, 59421250, 59448841 Model QD25: Lot No. 59046082,59046847,59052393,59052395,59056270,59059029,59060798,59062681,59069772,59073141,59077234,59079573,59085168,59085169,59097289,59101637,59106005,59110720,59122491,59126281,59131923,59140133,59142266,59143453,59145027,59158524,59158579,59163164,59184252,59191107,59201246,59207044,59209886,59214360,59214361,59216991,59222658,59222659,59233651,59246685,59246703,59255901,59268625,59284781,59287728,59296463,59299610,59313057,59320582,59320583,59334656,59344191,59346468,59352608,59356135,59360084,59374014,59374015,59414791,59425355,59437699,59437700,59448853
Product Distributed Qty 22,616
Reason For Recall Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

Event Detail

Event Id 65173
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Draper
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US Nationwide and country of Canada.
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