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New Search Back To Search Results   Medical Device Recalls Class 2 Recall Thoratec Date Recall Initiated January 26, 2004 Date Posted October 04, 2006 Recall Number Z-0015-2007 Product Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588 Code Information Serial Numbers: 104, 106 Recalling Firm/ Manufacturer Thoratec Corp 6035 Stoneridge Drive Pleasanton , California 94588-3270 For Addition Information Contact Donald A. Middlebrook 925-730-4117 Reason For Recall During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism. Action On 1/26/2004, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall. Quantity in Commerce 11 units Distribution Nationwide to 11(eleven) hospitals. The product was shipped within the United States in IL, MA, NC, MD, MO, FL, CA, AZ, PA, and NY. The product was distributed to one consignee in Australia.

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