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.

Detalles del retiro

Fabricante

Vascular Solutions, Inc.

Distribuidor

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.

Lote

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 30579 30579 30579 30579 30579 30579 30582 30582 30582 27295 29133 29131 27403 27660 28043 28050 28247 29133 30126 30579 28820 29133 29836 30126 30579 27401 28041 28048 28818 29453 29835 30580 562005 27658 28041 28048 28245 29131 29453 29835 30238 30580 28048 29453 29835 29835 29835 27401 27658 28041 28041 28048 28245 28818 29131 29453 29835 30238 30579 27401 27658 27658 28041 28041 28048 28048 28048 28245 28245 28245 28818 28818 29131 29453 29453 29835 29835 30238 30580 29131 28245 30579 30238 28048 30579 27295 27401 27658 28041 28245 28818 29453 29453 30580 27295 27401 28247 28247 28247 28820 28820 29133 29133 29133 29836 30126 30126 30579 30579 30579 30582 27658 28245 30126 29133 28048 28048 29133 30582 27660 27403 28820 27403 27403 27403 28043 28247 29133 27403 28050 28247 28247 27403 28043 28043 30126 27295 27660 28043 28247 28247 28820 29133 30579 27401 27658 28041 28041 28048 28048 28245 29131 29131 29132 29835 28001 29686 27215 27391 27656 28429 29456 27401 27658 27658 28041 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 276

Clasificación de riesgo

Class I

Área (FDA)

device

País

United States