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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1079-2013

CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

Publicado el 17 de abril de 2013 · Inicio del retiro: 29 de noviembre de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Thermo Fisher Scientific (Asheville) LLC
Distribuidor
Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.
Lote
Model 370: Serial #'s: 300028-325 to 30028-326; 300031-327 to 30031-331; 300111-332 to 30011-350; 300112-351 to 300112-365; 300113-366 to 300113-379; 300114-380 to 300114-383; 300208-386 to 300208-390; 300208-392 to 300208-397; 300209-398 to 300209-404; 300209-406 to 300209-411; 300210-412 to 300210-422; 300210-424; 300211-426 to 300211-444; 300285-445 to 300285-458; 300287-459 to 300287-466; 300288-467 to 300288-480; 300382-481 to 300382-494; 300383-495 to 300383-508; 300384-509 to 300384-522; 300385-523 to 300385-526; 300473-527 to 300473-531; 300474-532 to 300474-541; 300475-542 to 300475-551; 300476-552 to 300476-553; 3000551-384 to 300551-385; 300581-554 to 300581-563; 300583-564 to 300583-580; 300584-581 to 300584-600; 300670-601 to 300670-610; 300671-611 to 300671-624; 300672-625 to 300672-638; 300748-639 to 300748-650; 300749-651; 300750-653 to 300750-655; 300751-656 to 300751-659; 300840-660 to 300840-663; 300841-664 to 300841-667; 300842-668 to 300842-677; 300842-679 to 300842-683; 300843-684 to 300843-697; 300925-698 to 300925-707; 300925-709 to 300925-711; 300926-712 to 300926-725; 300927-726 to 300927-739; 300928-740 to 300928-751; 301005-752 to 301005-764; 301006-765 to 301006-781; 301007-782 to 301007-798; 301008-799 to 301008-814; 301080-815 to 301080-827; 301081-828 to 301081-837; 301082-838 to 301082-845; 301083-846 to 301083-857; 301204-858 to 301204-861; 301204-863: 301204-865 to 301204-867; 301204-871; 301205-872 to 301205-873; 301205-875 to 301205-884; 301206-885 to 301206-897; 301306-898 to 301306-907; 301391-908; 301391-911; 301391-914 to 301391-917; 301393-1032 to 301393-1039; 301479-918; 301480-919 to 301480-926; 301481-927 to 301481-932; 301584-933 to 301584-955; 301585-956 to 301585-971; 301586-972 to 301586-983; 301587-984 to 301587-994; 301678-1000 to 301678-1004; 301678-995 to 301678-999; 301679-1005 to 301679-1007; 301680-1008 to 301680-1010; 301771-1011 to 301771-1012; 301772-1013 to 301772-1017; 301773-1018 to 301773-1019; 301774-1026 to 301774-1031; 301795-1040 to 301795-1052; 301796-1053 to 301796-1063; 301797-1064 to 301797-1070; 301798-1071 to 301798-1081; 301888-1082 to 301888-1083; 301889-1084 to 301889-1086; 301890-1087 to 301890-1096; 301891-1097 to 301891-1106; 301980-1107 to 301980-1120; 301981-1121 to 301981-1133; 301982-1134 to 301982-1143; 301983-1144 to 301983-1152; 302066-1153 to 302066-1165; 302067-1166 to 302067-1178; 302068-1179 to 302068-1188; 302069-1189 to 302069-1196; 302156-1197 to 302156-1203; 302157-1204 to 302157-1219; 302158-1220 to 302158-1226; 302158-1228 to 302158-1233; 302243-1235 to 302243-1242; 302337-1243 to 302337-1248; 302338-1249 to 302338-1257; 302339-1258 to 302339-1265; 302340-1267 to 302340-1283; 302436-1284 to 302436-1303; 302437-1304 to 302437-1323; 302439-1324 to 302439-1341; 302539-1342 to 302539-1357; 302540-1358 to 302540-1367; 302541-1368 to 302541-1377; 302542-1378 to 302542-1388; 302626-1397 to 302626-1412; 302627-1413 to 302627-1433; 302628-1434 to 302628-1436; 302628-1438; 302629-1439 to 302629-1444; 302726-1445 to 302726-1450; 302727-1451 to 302727-1456; 302728-1457 to 302728-1462; 302839-1463 to 302839-1468; 302840-1469 to 302840-1477; 302841-1478 to 302841-1481; 302842-1484 to 302842-1487; 302937-1488 to 302937-1496; 302938-1497 to 302938-1504; 302939-1505 to 302939-1510; 302940-1511 to 302940-1513; 303043-1515 to 303043-1519; 303044-1522 to 303044-1528; 303045-1529 to 303045-1531; 303046-1532 to 303046-1540; 303125-1541 to 303125-1544; 303126-1545 to 303126-1561; 303127-1562 to 303127-1571; 303128-1572 to 303128-1584; 303213-1585 to 303213-1591; 303214-1592 to 303214-1613; 303215-1614 to 303215-1632; 303216-1633 to 303216-1644; 303303-1648 to 303303-1655; 303304-1656; 303305-1657 to 303305-1665; 303390-1666 to 303390-1673; 303391-1674 to 303391-1688; 303392-1689 to 303392-1703; 303393-1704 to 303393-1711; 303477-1714 to 303477-1728; 303478-1730 to 303478-1746; 303479-1747 to 303479-1755; 303479-1757 to 303479-1759; 303480-1760 to 303480-
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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