device · product 1 of 1
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
- Recall number
- Z-3210-2018
- Initiated
- June 15, 2018
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Medline Industries Inc
- Quantity
- 183,606 devices total
App-derived interpretation
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.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Inspect official wording and provenance
Reason for recall
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.
Code information
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)
Distribution pattern
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY