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U.S. Department of Health and Human Services

Class 2 Device Recall INTROFLEX VALVE INTRODUCER

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 Class 2 Recall
INTROFLEX VALVE INTRODUCER
see related information
Date Posted August 25, 2009
Recall Status1 Open
Recall Number Z-1913-2009
Recall Event ID 52629
Premarket Notification
510(K) Number
K981909 
Product Classification Introducer, Catheter - Product Code DYB
Product Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
Code Information Model Number: 1350BF85, Lot Numbers: 58501071, 58516969, 58545402, 58568606, 58584153, 58606248, 58624009, 58648809, 58503807, 58532828, 58549292, 58573256, 58594977, 58611630, 58626772, 58652695, 58511627, 58536781, 58552776, 58576340, 58598946, 58611631, 58630984, 58653740, 58516967, 58536782, 58559223, 58577684, 58602066, 58618047, 58636148, 58653741, 58516968, 58541155, 58559224, 58577685, 58606247, 5864008 and 58645016; Model Number: 1351BF7, Lot Numbers: 58530069, 58545403, 58598947 and 58657088; Model Number: 1351BF85H, Lot Numbers: 58526054, 58532992, 58534647, 58552777, 58559225, 58576341, 58594979, 58594980, 58598948, 58602067, 58624011, 58630985, 58636149, 58648810 and 58657097; Model Number: 1450BF85, Lot Numbers: 58511628, 58516970, 58577686, 58589282, 58598949, 58615054, 58624015, 58635275 and 58664034; Model Number: 1451BF6, Lot Numbers: 58506614, 58526055, 58562341, 58577589, 58594981, 58615056, 58621700, 58635275, 58657143 and 58664035; Model Number: 1451BF8, Lot Numbers: 58511629, 58514509, 58514513, 58530070, 58532829, 58541156, 58549294, 58556099, 58564225, 58568607, 58573257, 58584154, 58602069, 58606249, 58610319, 58615059, 58621701, 58648811, 58652696, 58660278 and 58685275; Model Number: 1452BF85H, Lot Numbers: 58503809, 58549295, 58576343, 58611633, 58630986 and 586652697; Model Number: 1550BF6C, Lot Numbers: 58499574, 58501074, 58530071, 58532830, 58562343, 58602070, 58626774 and 58652698; Model Number: 1550BF7C, Lot Numbers: 58564227, 58577700 and 58657145; Model Number: 1550BF8, Lot Numbers: 58499575, 58526057, 58549298, 58560116, 58564228 and 58573260; Model Number: 1550BF85, Lot Numbers: 58501075, 58530072, 58534652, 58536809, 58577701, 58598950, 58618048 and 58657146; Model Number: 1551BF85H, Lot Numbers: 58615062, 58630987 and 58652699; Model Number: 1650BF85, Lot Numbers: 58545404, 58564229, 58584155, 58589283, 58618049, 58645018 and 58660284; Model Number: 1651BF85, Lot Numbers: 58499633, 58501080, 58511630, 58541157, 58556100, 58559226, 58584156, 58602071, 58615072, 58621702, 58645019 and 58652700; Model Number: 1652BF85H, Lot Numbers: 58511631, 58549300, 58606253 and 58648812; Model Number: S310740C, Lot Number: 58550203; and Model Number: S5507BF85, Lot Numbers: 58496258, 58535112, 58604814 and 58644423.
Recalling Firm/
Manufacturer
Edwards Lifesciences, Llc
1 Edwards Way
Irvine, California 92614-5688
Manufacturer Reason
for Recall
Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.
Quantity in Commerce 67,357 Units
Distribution Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore.
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 = DYB and Original Applicant = BAXTER EDWARDS
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