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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.

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 Class 2 Recall
Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.
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Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0807-2012
Recall Event ID 60720
Premarket Notification
510(K) Number
K842375 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only, Sterile EO, Nonpyrogenic. Model number #'s : 67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, 69322, 69324, 69328, 69331, 69424, 69428, 69431, 69528, 69531. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Code Information Model # / Lot # 69431 67312 67314 67316 2009010377 2008110555 2008101197 200808C074 2009010733 2008110584 2008101198 2008110082 2009011144 2008110593 2008101199 2008110085 2009030545 2008110627 200810C087 2008110088 200903C053 2008110628 2008110326 2008110227 2009050720 2008110769 2008111018 2008110238 2009051020 2008110932 2008111019 2008110456 2009060260 2008111015 200811C088 2008110457 2009060955 2008111016 2008120221 2008110471 2009070017 2008111017 2008120393 2008111020 2009081561 2008111148 2008120655 2008111270 2009090939 2008111269 2008120946 2008120222 2009101695 2008120219 2008121120 2008120223 2009110293 2008120220 200812C091 2008120656 2010011405 2008120651 200812C235 2008120947 2010012934 2008120652 2009010204 2008121121 2010022294 2008120653 2009010205 2009010334 2010030396 2008120654 2009010332 2009011377 2010031095 2008120945 2009010333 2009020247 2010032967 200812C034 2009011124 2009020248 2010032968 2009010331 2009011375 2009020249 201003C057 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Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Manufacturer Reason
for Recall
Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
Quantity in Commerce 614,382
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = DLP, INC.
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