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U.S. Department of Health and Human Services

Class 1 Device Recall Guardian II and Guardian II NC Hemostasis Valve

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 Class 1 Recall
Guardian II and Guardian II NC Hemostasis Valve
see related information
Date Posted March 20, 2013
Recall Status1 Terminated on August 05, 2013
Recall Number Z-0955-2013
Recall Event ID 64511
Premarket Notification
510(K) Numbers
K092711  K101113  K122301 
Product Classification Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - Product Code DTL
Product Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.
Code Information Lot Number 29132 27295 27403 27660 27660 28050 28247 28247 28247 28247 28820 29133 29836 29836 30126 30579 30582 27658 28246 28246 29132 29132 29132 27658 27658 27658 28041 28041 28041 28048 28048 28245 28245 28245 28818 28818 28818 29131 30238 30580 27659 28049 29132 27294 27402 30582 31020 562784 27401 27658 27658 28041 28041 28245 28818 29131 29131 29453 29835 30238 27334 27397 27646 27646 27651 27779 28001 28006 28044 28051 28427 28817 29016 29016 29016 29137 29455 29455 29837 29837 30928 30930 30932 29454 28049 28246 28819 30581 27295 27403 27401 27658 28041 28245 28245 28245 28818 29453 29453 30580 28048 28001 28745 29016 29839 27403 31020 30579 27401 29131 30238 28048 28048 28050 30579 27295 27295 27295 27295 27295 27295 27295 27295 27403 27403 27403 27403 27660 27660 27660 27660 27660 28043 28043 28043 28043 28247 28247 28247 28247 28247 28247 28247 28247 28247 28820 28820 28820 28820 29133 29133 29133 29133 29836 29836 29836 29836 30126 30126 30126 30126 30579 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28048 28245 29131 29131 29453 29835 29835 30580 27401 27658 27658 28041 28048 28245 28245 28818 28818 29131 29453 29453 29835 30238 30238 30580 27294 28049 28246 28246 28819 29454 30578 28246 28245 28043 27401 28041 28245 27660 28048 29835 28245 27295 27403 27660 27660 28043 28247 28820 28820 28820 29836 27295 27295 27403 27403 28247 29836 30579 27658 28041 28041 29453 28246 28246 28819 29454 30581 27401 28245 28818 27658 27658 28245 30238 31020 27294 28049 28246 28819 29132 27402 27659 28042 28049 28246 28246 28246 28819 29454 30578 30578 27658 28041 28048 28048 28048 28245 28245 28818 28818 29453 29453 29453 29453 29453 30238 30580 29453 27401 27658 27658 27658 28048 28245 28245 28818 29131 29453 29835 30238 30580 30580 27294 27402 27659 28049 28246 28819 29132 29132 30578 30581 27399 28045 29130 30419 30935 27652 28047 27403 28043 30579 27295 27403 27403 28247 28820 29133 30126 30126 30582 29680 30213 27646 28044 28051 29455 29686 30211 27403 28247 28247 28247 27401 27295 27295 28245 29131 27401 27658 28041 28245 28245 28818 28818 30580 28041 30238 30581 30238 28041 29131 30238 28048 27401 27401 27401 27658 28041 28041 28048 28048 28245 28245 28245 28245 28818 28818 29131 29453 29453 29835 29835 30238 30580 30580 27401 28041 28041 28048 28048 28245 28245 28245 29131 29453 29453 30238 27401 27658 28041 28048 28245 28818 29131 29453 29453 30238 28245 29133 27294 27295 27295 28043 28247 30579 28051 27392 27392 27400 27400 27649 27657 27657 27657 28047 28054 28054 28054 28054 28430 29129 29135 29135 29458 29458 29834 29834 29834 29840 30068 30613 30613 30613 27216 27217 27217 27334 27334 27334 27334 27390 27392 27393 27393 27393 27393 27394 27394 27394 27395 27395 27397 27398 27398 27398 27398 27399 27646 27646 27649 27649 27649 27649 27650 27651 27651 27652 27652 27652 27655 27655 27657 27657 27779 27779 28001 28003 28003 28003 28004 28004 28006 28006 28006 28044 28044 28045 28045 28047 28047 28051 28052 28163 28163 28163 28163 28428 28428 28430 28430 28431 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30580 27401 27658 28048 28245 28818 29131 29453 29835 30580 28246 28246 29132 30578 30578 27294 28246 28819 30578 27658 28042 28818 29132 29453 29454 29835 30238 27660 28247 27401 27401 28041 28245 28245 28818 29131 29453 29835 28048 27401 27658 28041 28048 28245 28818 29453 29453 30238 28041 28245 28818 29131 29131 30238 29132 27658 28245 30238 27294 28049 28246 31020 31020 29130 29138 29141 29459 29839 30035 30419 30419 30609 30611 30931 30126 30126 30579 30582 30126 30126 31020 31020 31020 27403 27660 27295 27295 27295 27295 27295 27403 27403 27660 27660 27660 27660 28043 28043 28050 28247 28247 28247 28247 28247 28247 28820 28820 29133 29133 29133 29836 29836 30126 30126 30126 30579 30579 30582 29836 31020 28041 28245 27295 27401 30579 30579 30579 30579 27401 27401 27401 27401 27401 27658 27658 27658 28041 28041 28041 28041 28048 28048 28245 28818 28818 29131 29131 29453 29453 29835 29835 30238 30580 30580 27401 27401 27401 29131 27660 28247 28820 29133 29836 30582 557884 27295 28050 30579 27402 28246 28246 29454 27294 28246 29454 28247 28247 29133 29453 28247 30126 27401 28245 29131 27390 27647 27651 27652 27654 28427 28428 28539 28816 29842 29844 27660 27660 28048 27295 27295 27403 27660 28043 28043 28050 28247 28247 28820 28820 29133 29836 30126 30579 30579 28043 29836 29836 28043 27295 27403 27660 27660 28247 27216 27217 28002 29649 29833 29839 29844 29131 30580 28818 29131 28818 28049 28246 29132 30578 27295 27403 27660 28247 29836 30579 29453 27401 27401 27658 28041 28041 28048 28245 28818 28818 29131 29131 29453 29453 30238 30580 27295 27403 28050 29133 31020 27403 27660 28048 28246 28247 28247 27401 27401 27658 27658 28041 28041 28048 28048 28245 28245 28245 28245 28818 28818 28818 29131 29131 29131 29453 29453 29835 29835 30238 30580 28050 27403 27403 28043 28043 28050 28247 28247 28820 28820 29133 29836 29836 29836 29836 30126 30126 30579 30582 27403 28048 30238 28245 29453 29835 27403 28247 30126 27294 31020 31020 28050 28247 28247 29836 27660 28043 28247 29133 29836 28245 28818 29131 29131 29453 27401 27658 27658 28041 28245 28245 28245 28818 29453 29453 30579 27401 27658 27658 27658 28041 28048 28048 28245 28245 29131 29453 29835 30238 30580 28247 29133 30582 27294 27294 27402 27659 28042 28246 28246 28246 28246 28819 29131 29131 29453 29835 30238 30238 27658 28245 28245 29836 28050 30126 28245 28818 28818 29454 28246 27646 29686 27646 27652 29016 29453 27658 28041 28048 28048 28245 28245 28818 29131 29453 30580 29131 27393 27655 28046 28051 28745 29141 29459 29844 27399 27646 28001 28005 29134 29455 29459 29837 30211 27393 27397 27399 27390 27394 28001 28745 29837 29842 29835 29455 29686 27294 27402 28042 28246 28246 28819 29132 30578 30578 30579 30238 31020 31020 28246 29132 30578 27658 28245 28245 27658 28247 27401 28048 28245 29131 29131 31020 28245 27295 28245 27295 27403 27660 27660 27660 28247 28247 28820 28820 29133 30580 29131 27660 28050 28247 28050 28050 28050 29835 28245 28041 28245 28818 29453 29835 27403 28050 28247 28048 28245 28245 28247 28820 29835 28041 29453 27295 27295 27403 27660 28247 28247 27401 28245 30238 28247 28049 28819 27660 30579 27295 27295 27295 27403 27403 27660 28043 28247 28247 28247 28820 28820 29836 30126 30126 30126 30579 30582 28041 28818 29453 30580 27660 30579 27660 28247 27295 27295 27660 28247 28247 28820 30126 30579 30238 29131 29835 27401 28048 29835 27216 27392 27396 27396 27399 27648 27648 27652 27653 28003 28004 28004 28044 28428 28745 29129 29134 29134 29135 29458 29538 29538 29649 29680 29686 29834 29841 29844 28245 28043 28041 27401 28245 28818 29131 557887 30580 28247 28041 28245 29131 27401 27658 28041 28041 28048 28245 28818 29131 29453 29453 30238 30238 28820 27401 27295 27403 27660 28043 28247 28820 29836 30582 28245 29835 28246 28246 28819 28246 27401 28048 28245 27401 27401 27401 27658 27658 27658 27658 27658 28041 28041 28041 28041 28048 28048 28048 28245 28245 28245 28245 28246 28246 28818 28818 28818 28818 28818 29131 29131 29131 29453 29453 29453 29453 29835 29835 29835 30238 30238 30238 30580 30580 30580 28245 29453 28041 28818 29131 28042 28246 27294 27402 27659 27659 28049 28246 28246 28246 28819 29132 29132 30578 30578 27401 28041 28245 28818 29835, and 30238.
Recalling Firm/
Manufacturer
Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove, Minnesota 55369-6032
Manufacturer Reason
for Recall
Risk that air may be introduced into the device which may lead to an air embolism.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were sent a Vascular Solutions "Urgent Medical Device Recall" letter dated February 28, 2013. The letter described the problem and the product involved in the recall. In addition, consignees were advised to identify the location of and immediately remove the recalled product from their inventory and secure it. Consignees were requested to complete and return the VSI Account Inventory Form. The letter also stated that VSI Customer Service would contact customers within 1-2 business days after receiving the completed VSI Account Inventory Form. All returned affected product will be replaced upon receipt. Customers are to contact their local Sales Representative if they have any questions or concerns regarding this recall.
Quantity in Commerce 79,869
Distribution Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and countries of GREECE, DENMARK, AUSTRIA, UNITED KINGDOM, SWITZERLAND, IRELAND, INDIA, TURKEY, POLAND, HUNGARY, ITALY, EGYPT, KOREA, PORTUGAL HONG KONG, GERMANY, SPAIN, MEXICO, SWEDEN, NORWAY SLOVENIA, NETHERLANDS, and BELGIUM.
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 = DTL and Original Applicant = VASCULAR SOLUTIONS ZERUSA LTD.
510(K)s with Product Code = DTL and Original Applicant = ZERUSA LIMITED
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