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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
β οΈ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medline Industries Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3210-2018
Related Recalls
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.