Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 18,440 Galil Medical 2.1 CX Cryoablation Needles used in cryoablative procedures. The needles were distributed nationwide across all U.S. states and Canada. The devices are being recalled because the needle surface deteriorated due to unexpected electrolysis that occurred during procedures.
The affected devices are identified by UPN FPRPR3602 and GTIN 7290104831003, spanning multiple batch numbers from A0754 through A1609. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Reason for recall: The needle surface deteriorated due to unexpected electrolysis during procedure. 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. Quantity: 18440 devices Lot/code info: 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,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.