{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Maple Grove", "state": "MN", "country": "United States", "classification": "Class I", "openfda": {}, "product_type": "Devices", "event_id": "64511", "recalling_firm": "Vascular Solutions, Inc.", "address_1": "6464 Sycamore Ct N", "address_2": "N/A", "postal_code": "55369-6032", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "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.", "recall_number": "Z-0955-2013", "product_description": "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.", "product_quantity": "79,869", "reason_for_recall": "Risk that air may be introduced into the device which may lead to an air embolism.", "recall_initiation_date": "20130227", "center_classification_date": "20130320", "termination_date": "20130805", "report_date": "20130327", "code_info": "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 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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 28431 28431 28538 28538 28538 28538 28538 28745 28745 28817 28817 29134 29134 29134 29134 29134 29134 29134 29137 29137 29137 29141 29141 29455 29457 29457 29457 29457 29458 29458 29649 29649 29686 29686 29834 29834 29839 29839 29839 29839 29839 29839 29841 29841 29841 29844 30213 30609 30611 30611 30614 30614 30614 30737 30737 30737 30928 30928 30929 30929 30934 30934 30935 30936 30936 31102 31242 31243 31418 27650 27655 28007 28536 28815 29016 29130 29141 29833 30609 30609 30935 30935 27295 28819 27658 28245 28245 29453 29835 27659 28246 27659 28246 28246 29132 30581 27401 27401 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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." } ] }