Z-3210-2018 Class II Terminated

Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING, DBL, SAME END - 500 EA/CS, 50 EA/BX, 10 BX/CS; d. Item Number DYK1002SBC, BRUSH, CLEANING, SINGLE END - 500 EA/CS, 50 EA/BX, 10 BX/CS

There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

Endoscopic cleaning brush finished good lot numbers: GM10, GJ25, HA05, HA20. Kits: a. Item Number DYK1002DCB, kit Number (Kit Lot Number): DYK1001DCB (18BA0735), DYK1002144B (18BA0644, 18DA0124), DYK1008972E (18BA2199, 18DA1418, 18EAA023, 18EAA653), DYK1012268E1 (18BA1667, 18CA0872, 18CA1289, 18DA1732), DYK1012414E1 (18CA0793, 18CA1644, 18DA0413), DYK1017922E (18CA1300), DYK1018542E (18CA0622, 18DA1159, 18EAB507), DYK1044978E (18EBE085, 18NB1289), DYK1067817E1 (18AA1969, 18EAA004, 18EAB365), DYK1072097E (18DA0437, 18EAA790), DYK1097615E (18CA0687, 18EAA084), DYK1177017E (18BA2352, 18DA1481), DYK1188722E (18EAA016, 18EAB529), DYK1253578E (18AA2092, 18DA0331), DYK1253578F (18DA1595), DYK1266757E (18BA0203, 18DA0062, 18DF0085), DYKE1003A (18DA1488, 18FAA025), DYKE1011B (18AA1276), DYKE1012C (18DA0090, 18EAA521), DYKE1013 (18CB4388, 18EBL745), DYKE1014B (17KA1195, 18AA0984, 18CA0691, 18CA1969, 18DA0344, 18DA1167), DYKE1022A (18EBE830), DYKE1029C (18BA0279, 18CA0842), DYKE1032C (18BB1877, 18BB6935, 18EBH874, 18EBS890, 18OB9988), DYKE1033B (18MB9361), DYKE1033C (18CB1145, 18DB0018, 18EBH875), DYKE1037 (18CA1072, 18DA0377), DYKE1043C (18DA0411, 18EAA198), DYKE1048 (18BA0550), DYKE1050 (18BA0830, 18CA1744, 18EAA936), DYKE1056C (18DA0952, 18EBF206, 18EBF513, 18EBN896, 18PB3439), DYKE1058A (18BB6939, 18CB5355, 18PB4193), DYKE1059A (18BB582118EBF514), DYKE1062A (18CA1504), DYKE1062B (18EAB341), DYKE1063 (18BB4018, 18EBL836, 18OB2537, 18PB6224), DYKE1064 (18BB2161, 18DB8246, 18EBL833), DYKE1069A (18CA0564, 18CA1222), DYKE1069B (18DA0510), DYKE1072 (18BA0524, 18DA0412, 18EAA070), DYKE1077 (18BA1594, 18DA0096, 18EAB672), DYKE1096A (18BA1239, 18DA0345, 18FAA190), DYKE1099 (18BA1707), DYKE1108C (17JA2124, 17KA1225), DYKE1108D (18AA2499, 18BA1296, 18CA0336), DYKE1112 (18CA0139), DYKE1120 (18BA2330, 18DA0523, 18EAB011), DYKE1123 (18CA0181, 18DA0779, 18EAB549), DYKE1126A (18BA0589, 18CA1597), DYKE1138A (18BA1559, 18CA2056), DYKE1143A (18BA0473), DYKE1152 (18DA1187, 18EAA714), DYKE1158A (18BA2208, 18EAA253, 18EAB695, 18FAA253), DYKE1159A (18FAA227), DYKE1161A (18BA1435, 18EAB349), DYKE1162G (17JA2795), DYKE1162I (18AA1616, 18AA2211, 18BA0354), DYKE1162J (18BA1753, 18DA1469), DYKE1164 (18EBD023, 18OB2534), DYKE1172C (18EAA129), DYKE1176 (18CA1092, 18DA1719), DYKE1184B (17IA1038, 17JA1424, 17LA1730, 18BA1937, 18DA1028), DYKE1185 (18CA1513), DYKE1203A (18DA0680, 18FAA307), DYKE1207 (18BA1174, 18CA0313, 18EAA076, 18EAA397), DYKE1224C (18DA0018, 18EAA709), DYKE1232 (18CA0337, 18EAA730), DYKE1233 (18AA1392, 18BA0937, 18DA0390, 18DB7237, 18EBG997, 18EBT332), DYKE1234 (18FAA404), DYKE1245 (18BA0307, 18BA0908), DYKE1249 (18BA1440, 18DA1612, 18FAA258), DYKE1250 (18BA2009, 18EAA141), DYKE1258 (18BA1480, 18EAA325), DYKE1265 (18DA0068, 18DA0206, 18EAB322, 18EAB747), DYKE1274A (18CA0987, 18EAB342), DYKE1293 (18BA0492, 18CA1224, 18DA1377, 18EAB042), DYKE1295 (18BA0770, 18CA1963, 18DA1479), DYKE1303 (18MB9887, 18OB2532), DYKE1304 (18BB5870, 18DB7236), DYKE1308 (18CA0292, 18DA0841), DYKE1313B (18CA1559, 18EAB036), DYKE1314A (18CA1327), DYKE1318 (18BA0888, 18DA1352, 18FAA368), DYKE1332A (18EAA061), DYKE1333 (18BA0763, 18EAA432), DYKE1334B (18BA0597, 18EAA447), DYKE1345 (18CA1207, 18DA1486), DYKE1350A (18BB2129, 18DB7371, 18EBO982), DYKE1357B (18CA0267), DYKE1357C (18DA1208, 18FAA100), DYKE1364A (17LA1129, 18BA0029, 18DB7239, 18EBD050), DYKE1366 (18BA0796, 18CA1707, 18EAB410), DYKE1369C (17JA2209, 17LA2210, 18BA0882, 18CA1422), DYKE1372 (18NB4423), DYKE1375A (18BA1778, 18CA2032), DYKE1385 (18BA0562, 18CA1193, 18EAA304), DYKE1386 (18CA0393, 18DA0589, 18FAA222), DYKE1391 (18EAB593), DYKE1393A (18BA0591, 18CA1406, 18DA0833, 18EAA789), DYKE1395A (18CA0886, 18DA0717, 18FAA293), DYKE1399 (18DA0204, 18EAA422, 18FAA144), DYKE1402 (18BB5817, 18DB7373, 18EBS803), DYKE1406 (18CA0328, 18DA0091), DYKE1409 (18DA0216, 18EAB769), DYKE1410 (18BA0708, 18CA0837, 18DA1564, 18EAA453), DYKE1415 (18CA1723, 18DA1887, 18EAB265), DYKE1416 (18DA1072, 18EAA886), DYKE1422A (18BA1978, 18DA1468), DYKE1423A (18CA1662, 18DA1174, 18EAA686), DYKE1431B (18BA0503, 18DA1586, 18EAA301, 18EAB901), DYKE1438A (18AA1176), DYKE1438B (18CA0630, 18EAB038), DYKE1441B (18DA1320, 18DA1745, 18EAB829), DYKE1442A (18DB7372, 18NB2540), DYKE1448 (18BA1463, 18CA1544), DYKE1455 (18CA0109, 18EAA273, 18EAB548), DYKE1456 (18BA0145, 18CA0268, 18DA0642, 18EAA706), DYKE1457 (18BA0626, 18EAA078), DYKE1460 (18AA2138, 18CA1928, 18EAB528), DYKE1466 (18BA1634, 18CA1187, 18DA1776), DYKE1468 (18BA1335, 18EAB838), DYKE1469A (18BA0868, 18DA1474), DYKE1475A (17LA0444, 18AA2019, 18BA1162, 18CA1545), DYKE1480 (18BA0028, 18BA0211, 18BB6704, 18EBQ945, 18OB9926, 18PB5260), DYKE1481 (18BA1471, 18CA1402, 18DA1569, 18EAB051), DYKE1487A (18AA2145, 18BA1736), DYKE1487B (18DA0599), DYKE1488 (18DB7238, 18EBE095), DYKE1491 (18DA0948), DYKE1494 (18BA1450, 18DA1778), DYKE1498 (18CA0824), DYKE1503B (17LA0480, 18AA0783, 18BA0551, 18CA0587, 18DA0778, 18EAA371, 18FAA192), DYKE1506 (18FAA157), DYKE1507 (18DA0591, 18EAB736, 18FAA039), DYKE1516A (18AA1029, 18BA0055, 18BA1034, 18EAB049), DYKE1519 (17IA0093, 18BA1540, 18CA1650, 18EAA320), DYKE1521 (17IA2305, 17JA2046), DYKE1521A (17LA1124, 17LA2004, 18AA2110, 18DA0535), DYKE1526 (17JA0857, 17KA1032, 18AA2090), DYKE1526A (18BA1336, 18CA1705, 18DA1783, 18EAA523, 18FAA247), DYKE1527 (17IA1501, 17KA1034, 18AA0950, 18CA1957, 18DA1731, 18EAB046), DYKE1535 (17JA1057, 17LA0481, 18AA2114, 18DA1728), DYKE1536 (17JA0776, 17KA1944, 18AA1963, 18BA1970, 18DA0211, 18EAA468), DYKE1537 (17JA1066), DYKE1538 (17LA0810, 18BA0475, 18BA2349, 18DA1031, 18EAB415), DYKE1543 (17KA0386, 17LA1373, 18AA2292), DYKE1554 (18AA0653, 18CA1845), DYKE1555 (17LA1505), DYKE1559 (18AA1924, 18BA0444), DYKE1561 (18BA1796, 18DA0372, 18EAB826), DYKE1564 (18CA1183, 18EAA246), DYKE1567 (18CA0739), DYKE1573 (18EAA049, 18FAA288), DYKE1574 (18DA1130, 18DA1594), DYKE1579 (18EAB289, 18EAB583), DYKE1586 (18EAB222), DYKE1588 (18FAA342), DYKE18CMPLY (18CA1467), DYKENDOBASIC (18CA0995, 18DA1811, 18FAA369), DYKENDOBPLUS (18BA1853, 18DA1190, 18FAA207), DYKENDOCLEAN (18DA0382, 18EAB587), DYKENDOCMPLY (18BA1056, 18CA0124, 18DA0129, 18EAB667), DYKENDODBCMP (18BA0916, 18DA0383, 18EAA260, 18EAB752), DYKENDOLWCMP (18DA1812, 18FAA202), DYKENDOUPCMP (18BA1854, 18DA0718, 18EAA508), DYKM1404 (18CA1636, 18DA0654), DYKM1555 (17JA1068, 17LA1482, 18AA1177, 18AA2029, 18AA2612, 18CA0565, 18DA0069, 18EAA433), DYSAMP200458 (18DA1963), DYSAMP200460 (18FAA265), P880995 (18EKD315), P881009 (18EAA498), P971311 (18BA0897, 18CA1642, 18DA0859, 18EAA859), PHS347468000 (18DK2120, 18FKB069); b. Item Number DYK1002DBDE, kit Number (Kit Lot Number): DYK1001DBDE (17IA0598, 17LA0129), DYK1002DBDE (18BA0041), DYK1276244E1 (17JA0713), DYKE1122C (17JA0877, 17JA1514, 17JA2093, 17LA0460, 17LA1984, 18BA2299, 18CA0795, 18CA1927, 18EAA705), DYKE1446A (17JA2156, 17LA1648, 18BA0062, 18CA1226, 18DA1726), DYKE1447A (17IA1474, 17LA1178, 18BA0942), DYKE1516 (17HA1857, 17JA2263), DYKE1539 (17JA1281, 17KA1644, 18AA2157), DYKE1540 (17KA1547), DYKE1540A (18BA0740, 18CA1706, 18DA1020, 18EAB360), DYKE1552 (17LA1291, 18CA0448, 18CA0843), DYKE1580 (18EAA623, 18FAA191); c. Item Number DYK1002DBSE, kit Number (Kit Lot Number): DYK1091457E1 (17LA2255, 18CA0974, 18EAA258), DYK1245641E (17LA1486, 18CA1307), DYKE1000A (17LA0061, 17LA1462, 18CA1093, 18EAA814), DYKE1071 (17LA1174, 18AA0941, 18AA1383), DYKE1110 (18AA1490, 18CA0971, 18DA1557), DYKE1131 (18CA0972, 18EAA321), DYKE1135 (18AA0928, 18BA2275), DYKE1136B (18AA0807, 18AA2529, 18CA0970), DYKE1142 (18AA1125, 18DA0283, 18EAA075), DYKE1144 (18AA0905, 18BA0411, 18CA1924), DYKE1156 (18AA1587, 18CA0976), DYKE1157 (18BA1683, 18CA0975, 18DA1464), DYKE1193 (18AA2159, 18DA0924), DYKE1200B (18AA0869, 18BA2046, 18DA1022), DYKE1201C (17LA2024), DYKE1222B (18AA1458, 18DA0221), DYKE1307A (17JA0617, 17LA1157, 18AA0914, 18CA0967, 18CA1964, 18DA1473), DYKE1392 (17LA1416, 18AA0963, 18DA0376), DYKE1424A (18AA2437, 18CA0985, 18DA1013), DYKE1462A (18BA1818, 18DA1309, 18EAA071), DYKE1505A (17LA2183, 18DA1017), DYKE1533 (17JA0051, 18CA1355), DYKE1581 (18EAA459); d. Item Number DYK1002SBC, kit Number (Kit Lot Number): DYKE1098A (17KA0949, 17LA0422, 18BA0284, 18CA1966, 18DA1296, 18EAA950), DYKE1105 (17JA2744, 17KA1969, 18BB5818, 18EBU560), DYKE1294 (18AA0754), DYKE1363 (17LA0251), DYKE1493 (17KA2116), DYKE1560 (18BA1585, 18DA0003)