Ablation Galil Technology recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UPN: FPRPR3602, GTIN: 7290104831003, Batch: A0754, A0755, A0758, A0759, A0770, A0771, A0782, A0783, A0788, A0789, A0794, A0795, A0803, A0804, A0827, A0828, A0833, A0834, A0844, A0845, A0856, A0857, A0871, A0872, A0880, A0881, A0894, A0895, A0905, A0906, A0907, A0908, A0922, A0923, A0925, A0926, A0930, A0931, A0939, A0940, A0941, A0942, A0952, A0953, A0956, A0957, A0958, A0959, A0972, A0973, A0974, A0975, A0996, A0997, A0999, A1000, A1010, A1011, A1017, A1018, A1034, A1035, A1036, A1037, A1042, A1043, A1045, A1073, A1074, A1076, A1077, A1088, A1089, A1093, A1094, A1100, A1101, A1127, A1128, A1172, A1173, A1129, A1130, A1131, A1132, A1135, A1136, A1214, A1215, A1228, A1229, A1243, A1244, A1246, A1247, A1258, A1259, A1266, A1267, A1659, A1660, A1661, A1662, A1670, A1671, A1676, A1677, A1696, A1697, A1698, A1699, A1702, A1703, A1704, A1705, A1708, A1709, A1736, A1737, A1740, A1741, A1742, A1743, A1269, A1270, A1289, A1290, A1315, A1316, A1330, A1331, A1332, A1333, A1338, A1339, A1345, A1346, A1350, A1351, A1352, A1353, A1354, A1355, A1357, A1358, A1359, A1360, A1361, A1362, A1365, A1366, A1371, A1372, A1375, A1376, A1380, A1381, A1383, A1384, A1385, A1386, A1387, A1388, A1389, A1390, A1397, A1398, A1406, A1407, A1414, A1415, A1425, A1426, A1431, A1432, A1445, A1446, A1452, A1453, A1462, A1463, A1467, A1468, A1469, A1470, A1491, A1492, A1493, A1494, A1503, A1504, A1536, A1537, A1542, A1543, A1557, A1558, A1570, A1571, A1584, A1585, A1594, A1595, A1597, A1598, X6924, A1608, A1609, A1622, A1623, A1624, A1625, A1630, A1631, A1637, A1638, A1641, A1642, A1744, A1745, A1751, A1752, A1770, A1771, A1777, A1778, A1783, A1784, A1787, A1788, A1789, A1790, A1795, A1796, A1805, A1806, A1814, A1815, A1826, A1827, A1835, A1836, A1840, A1841, A1842, A1843, A1849, A1850, A1851, A1852, A1855, A1856, A1859, A1860, A1862, A1863, A1867, A1868, A1881, A1882, A1887, A1888, A1899, A1900, A1903, A1904, A1907, A1908, A1913, A1914, A1916, A1917, A1918, A1919, A1920, A1921, A1938, A1939, A1940, A1941, A1931, A1932, A1952, A1953, A1957, A1958, A1963, A1964, A1969, A1970, A1980, A1981, A1992, A1993, A1995, A1996, A2004, A2005, A2014, A2015, A2027, A2028, A2031, A2032, A2046, A2047, A2051, A2052, A2056, A2057, A2084, A2085, A2111, A2112, A2125, A2126, A2134, A2135, A2139, A2140, A6636, A6637, A6638, A6639, A6651, A6652, A6674, A6675, A6683, A6684, A6703, A6704, A6724, A6725, A6728, A6759, A6760, A6763, A6764, A6765, A6766, A6783, A6784, A6803, A6804, A6805, A6806, A6841, A6842, A6850, A6851, A6858, A6859, A6862, A6863, A6868, A6869, A6874, A6875, A6876, A6877, A6881, A6882, A6887, A6888, A6894, A6895, A6904, A6905, A6909, A6910, A6919, A6920, A6921, A6922, A6934, A6935, A6936, A6937, A6938, A6939, A6946, A6947, A6954, A6955, A6959, A6973, A6974, A6996, A6997, A7023, A7024, A7041, A7047, A7054, A7050, A7051, A7055, A7056, A7057, A7058, A7059, A7060, A7096, A7097, A7080, A7081, A7086, A7087, A7089, A7090, A7092, A7093, A7094, A7095, A7098, A7099, A7107, A7108, A7109, A7128, A7129, A7130, A7131, A7140, A7141, A7142, A7144, A7146, A7147, A7151, A7152, A7177, A7178, A7189, A7190, A7191, A7192, A7199, A7200, A7207, A7208, A7209, A7210, A7221, A7222, A7229, A7230, T0004, T0007, T0038, T0039, T0046, T0047, T0048, T0049, T0076, T0077, T0082, T0083, T0085, T0086, T0087, T0088, T0089, T0090, T0095, T0096, T0097, T0098, T0105, T0106, T0107, T0108, T0109, T0110, T0113, T0114, T0120, T0121, T0122, T0124, T0139, T0140, T0406, T0147, T0148, T0159, T0160, T0164, T0165, T0168, T0169, T0174, T0175, T0176, T0177, T0183, T0184, T0185, T0186, T0190, T0191, T0194, T0195, T0199, T0200, T0206, T0207, T0208, T0209, T0217, T0218, T0220, T0221, T0225, T0226, T0227, T0228, T0229, T0230, T0231, T0232, T0239, T0240, T0241, T0242, T0243, T0244, T0255, T0256, T0264, T0265, T0276, T0277, T0279, T0280, T0287, T0288, T0289, T0290, T0291, T0292, T0316, T0309, T0310, T0320, T0321, T0322, T0323, T0331, T0332, T0334, T0335, T0336, T0337, T0338, T0343, T0344, T0376, T0377, T0382, T0396, T0398, T0399, T0404, T0405, T0420, T0421, T0422, T0423, T0424, T0425, T0426, T0427, T0435, T0436, T0446, T0447, T0459, T0460, T0471, T0472, T0477, T0478, T0479, T0480, T0481, T0482, T0494, T0495, T0496, T0497, T0500, T0501, T0505, T0506, T0508, T0509, T0510, T0513, T0514, T0516, T0517, T0518, T0519, T0525, T0526, T0534, T0535, T0543, T0545, T0548, T0549, T0553, T0554, T0563, T0564, T0568, T0569, T0573, T0574, T0575, T0576, T0579, T0580, T0581, T0582, T0585, T0586, T0612, T0613, T0622, T0623, T0624, T0625, T0626, T0627, T0628, T0629, T0630, T0631, T0637, T0638, T0639, T0640, T0641, T0642, T0643, T0644, T0645, T0646, T0661, T0662, T0708, T0709, T0684, T0685, T0727, T0728, T0729, T0730, T0714, T0717, T0715, T0716, T0733, T0734, T0737, T0781, T0738, T0739, T0740, T0742, T0741, T0743, T0744, T0782, T0808, T0809, T0810, T0811, T0812, U0022, U0023, U0024, U0025, U0026, U0048, U0049, U0055, U0056, U0076, U0077, U0078, U0079, U0080, U0081, U0090, U0096, U0097, U0100, U0101, U0104, U0105, U0106, U0107, U0110, U0111, U0138, U0139, U0140, U0141, U0142, U0143, U0144, U0145, U0162, U0163, U0170, U0171, U0190, U0191

Product

Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended…

Recalling firm

Boston Scientific Corporation

Quantity

18440 devices

Distribution

Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.

Recall date

July 29, 2020

Classification

Class II

Status

Terminated

Agency

FDA (device)