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U.S. Department of Health and Human Services

Class 2 Device Recall IceFORCE" Cryoablation Needles

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  Class 2 Device Recall IceFORCE" Cryoablation Needles see related information
Date Initiated by Firm November 18, 2020
Create Date December 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-0657-2021
Recall Event ID 86777
510(K)Number K152133  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product IceFORCE" 2.1 CX 90¿ Cryoablation Needle
Code Information UPN: FPRPR3602  UDIs: 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 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U1347, U1338, U1340, U1342, U1344, U1346, U1348, U1354, U1352, U1358, U1356, U1350, U1345, U1341, U1343, U1339, U1298, U1296, U1294, U1292, U1290, U1288, U1286, U1284, U1282, U1280, U1278, U1276, U1274, U1273, U1279, U1283, U1285, U1287, U1291, U1293, U1277, U1297, U1281, U1275, U1289, U1295, U1260, U1258, U1256, U1254, U1252, U1204, U1246, U1247, U1249, U1251, U1253, U1255, U1257, U1259, U1243, U1241, U1245, U1250, U1248, U1244, U1242, U1202, U1200, U1198, U1185, U1189, U1191, U1192, U1193, U1197, U1199, U1203, U1187, U1195, U1201, U1196, U1194, U1190, U1188, U1186, U1163, U1164, U1159, U1157, U1155, U1151, U1149, U1147, U1143, U1141, U1132, U1134, U1136, U1140, U1142, U1145, U1148, U1152, U1153, U1154, U1156, U1146, U1144, U1150, U1138, U1158, U1139, U1137, U1135, U1133, U1116, U1107, U1105, U1102, U1101, U1108, U1099, U1106, U1097, U1098, U1100, U1103, U1096, U1104, U1095, U1092, U1073, U1072, U1063, U1062, U1065, U1060, U1064, U1061, U1059, U1056, U1058, U1055, U1008, U1003, U1004, U1002, U1000, U0998, U0996, U0992, U0995, U1001, U1005, U1006, U1007, U0993, U0999, U0997, U0991, U0994, U0942, U0937, U0936, U0934, U0932, U0929, U0928, U0926, U0927, U0930, U0931, U0933, U0935, U0938, U0940, U0939, U0900, U0896, U0894, U0892, U0891, U0893, U0895, U0897, U0899, U0890, U0898, U0901, U0855, U0853, U0851, U0849, U0847, U0845, U0843, U0844, U0850, U0852, U0854, U0842, U0848, U0846, U0838, U0839, U0840, U0841, U0807, U0810, U0797, U0794, U0791, U0793, U0795, U0796, U0798, U0801, U0804, U0805, U0808, U0809, U0799, U0802, U0800, U0803, U0806, U0787, U0788, U0789, U0792, U0790, U0762, U0760, U0758, U0754, U0751, U0747, U0749, U0750, U0752, U0753, U0755, U0756, U0761, U0759, U0757, U0748, U0769, U0723, U0719, U0709, U0715, U0716, U0718, U0720, U0721, U0724, U0726, U0707, U0713, U0710, U0711, U0722, U0725, U0717, U0714, U0712, U0708, U0688, U0682, U0680, U0678, U0674, U0670, U0672, U0668, U0665, U0666, U0662, U0663, U0667, U0669, U0675, U0681, U0683, U0684, U0685, U0673, U0676, U0679, U0677, U0671, U0664, U0639, U0637, U0635, U0633, U0630, U0608, U0628, U0631, U0632, U0636, U0638, U0607, U0626, U0634, U0629, U0627, U0606, U0604, U0602, U0600, U0579, U0575, U0578, U0580, U0597, U0599, U0605, U0603, U0598, U0601, U0577, U0576, U0573, U0574, U0572, U0570, U0567, U0569, U0571, U0565, U0568, U0566, U0556, U0557, U0551, U0550, U0549, U0548, U0546, U0547, U0543, U0544, U0490, U0509, U0488, U0489, U0486, U0480, U0481, U0483, U0485, U0487, U0482, U0484, U0458, U0457, U0456, U0454, U0452, U0453, U0423, U0424, U0361, U0362, U0360, U0358, U0317, U0316, U0359, U0357, U0312, U0314, U0313, U0311, U0309, U0306, U0308, U0315, U0310, U0307, U0277, U0276, U0274, U0272, U0270, U0267, U0268, U0263, U0264, U0265, U0269, U0271, U0275, U0278, U0273, U0266, U0225, U0224, U0222, U0223, U0190, U0191, U0187, U0170, U0171, U0163, U0162, U0145, U0142, U0141, U0138, U0139, U0140, U0143, U0144, U0110, U0111, U0106, U0107, U0104, U0105, U0101, U0100, U0097, U0096, U0090, U0080, U0079, U0076, U0078, U0081, U0077, U0056, U0055, U0049, U0048, U0026, U0024, U0023, U0022, U0025, T0811, T0812, T0810, T0808, T0809, T0744, T0743, T0742, T0739, T0781, T0782, T0734, T0716, T0733, T0740, T0737, T0738, T0741, T0714, T0729, T0730, T0727, T0728, T0715, T0717, T0709, T0708, T0685, T0684, T0661, T0662, T0641, T0643, T0644, T0646, T0645, T0642, T0637, T0638, T0639, T0640, T0628, T0629, T0630, T0631, T0624, T0627, T0625, T0622, T0626, T0623, T0612, T0613, T0586, T0585, T0582, T0581, T0579, T0580, T0575, T0576, T0574, T0573, T0569, T0568, T0564, T0563, T0553, T0554, T0548, T0549, T0545, T0543, T0534, T0535, T0526, T0525, T0518, T0519, T0517, T0516, T0514, T0513, T0508, T0509, T0510, T0506, T0505, T0500, T0501, T0497, T0496, T0494, T0495, T0481, T0482, T0479, T0480, T0478, T0477, T0471, T0472, T0460, T0459, T0447, T0446, T0435, T0436, T0427, T0426, T0424, T0425, T0421, T0422, T0423, T0420, T0406, T0404, T0405, T0399, T0398, T0396, T0382, T0377, T0376, T0344, T0343, T0338, T0337, T0336, T0334, T0335, T0332, T0331, T0320, T0323, T0321, T0322, T0316, T0309, T0310, T0292, T0291, T0289, T0290, T0288, T0287, T0280, T0279, T0277, T0276, T0265, T0264, T0256, T0255, T0241, T0244, T0242, T0243, T0239, T0240, T0232, T0231, T0226, T0227, T0228, T0229, T0230, T0225, T0221, T0220, T0217, T0218, T0208, T0209, T0207, T0206, T0200, T0199, T0194, T0195, T0191, T0190, T0185, T0186, T0183, T0184, T0176, T0177, T0174, T0175, T0169, T0168, T0164, T0165, T0159, T0160, T0147, T0148, T0140, T0139, T0124, T0122, T0121, T0120, T0114, T0113, T0110, T0109, T0108, T0107, T0105, T0106, T0098, T0097, T0096, T0095, T0090, T0089, T0087, T0088, T0085, T0086, T0083, T0082, T0076, T0077, T0046, T0047, T0048, T0049, T0039, T0038, T0007, T0004, A7229, A7230, A7221, A7222, A7209, A7210, A7208, A7207, A7200, A7199, A7191, A7192, A7190, A7189, A7177, A7178, A7151, A7152, A7146, A7147, A7144, A7142, A7140, A7141, A7131, A7130, A7128, A7129, A7107, A7108, A7109, A7098, A7099, A7097, A7095, A7092, A7096, A7094, A7093, A7090, A7089, A7087, A7086, A7080, A7081, A7055, A7056, A7057, A7058, A7059, A7060, A7054, A7051, A7050, A7047, A7041, A7023, A7024, A6997, A6996, X6979, A6973, A6974, A6959, A6954, A6955, A6947, A6946, A6939, A6938, A6936, A6937, A6935, A6934, X6924, A6922, A6921, A6919, A6920, A6909, A6910, A6905, A6904, A6895, A6894, A6888, A6887, A6882, A6881, A6874, A6875, A6877, A6876, A6869, A6868, A6862, A6863, A6859, A6858, A6851, A6850, A6841, A6842, X6837, A6803, A6804, A6805, A6806, A6784, A6783, A6763, A6764, A6765, A6766, A6760, A6759, A6728, A6724, A6725, A6703, A6704, A6683, A6684, A6674, A6675, A6652, A6651, A6639, A6638, A6636, A6637, A2140, A2139, A2134, A2135, A2125, A2126, A2112, A2111, A2085, A2084, A2056, A2057, A2052, A2051, A2046, A2047, A2032, A2031, A2028, A2027, A2014, A2015, A2004, A2005, A1995, A1996, A1993, A1992, A1980, A1981, A1970, A1969, A1963, A1964, A1958, A1957, A1952, A1953, A1940, A1941, A1938, A1939, A1931, A1932, A1921, A1920, A1918, A1919, A1917, A1916, A1913, A1914, A1907, A1908, A1904, A1903, A1900, A1899, A1888, A1887, A1882, A1881, A1868, A1867, A1862, A1863, A1859, A1860, A1856, A1855, A1850, A1851, A1852, A1849, A1842, A1843, A1840, A1841, A1835, A1836, A1827, A1826, A1814, A1815, A1805, A1806, A1796, A1795, A1790, A1787, A1788, A1789, A1783, A1784, A1777, A1778, A1770, A1771, A1751, A1752, A1744, A1745, A1743, A1742, A1740, A1741, A1737, A1736, A1709, A1708, A1705, A1702, A1703, A1704, A1697, A1698, A1699, A1696, A1676, A1677, A1671, A1670, A1660, A1661, A1662, A1659, A1641, A1642, A1638, A1637, A1631, A1630, A1622, A1623, A1624, A1625, A1608, A1609, A1598, A1597, A1594, A1595, A1584, A1585, A1571, A1570, A1557, A1558, A1542, A1543, A1536, A1537, A1503, A1504, A1493, A1494, A1491, A1492, A1470, A1469, A1468, A1467, A1462, A1463, A1452, A1453, A1445, A1446, A1431, A1432, A1426, A1425, A1414, A1415, A1406, A1407, A1397, A1398, A1390, A1389, A1388, A1387, A1385, A1386, A1384, A1383, A1381, A1380, A1375, A1376, A1372, A1371, A1365, A1366, A1361, A1362, A1359, A1360, A1358, A1357, A1355, A1354, A1352, A1353, A1351, A1350, A1346, A1345, A1338, A1339, A1333, A1332, A1331, A1330, A1315, A1316, A1289, A1290, A1269, A1270, A1266, A1267, A1258, A1259, A1247, A1246, A1243, A1244, A1228, A1229, A1215, A1214
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Nicole Pshon
763-494-1700
Manufacturer Reason
for Recall		 Complaint trend regarding needle shaft gas leaks.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers will be sent a product advisory via overnight mail.
Quantity in Commerce 22,289 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = GALIL MEDICAL LTD
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