Z-1466-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- February 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 315,716 units
Product Description
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Reason for Recall
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
Code Information
Product Number/CFN: OMS-T10BTNL; UDI/DI: 20884521527383, 10884521527386; Lot Serial Number: P0L1440, P0L1441, P0M1916, P0M1916, P0M1941, P1A1541, P1A1541, P1C0413, P1C0413, P1C0414, P1C0414, P1C0415, P1C0415, P1C1569, P1C1570, P1C1669, P1C1669, P1C1670, P1C1670, P1C1671, P1C1672, P1C1792, P1C1793, P1C1793, P1C1921, P1C1922, P1C1923, P1D0373, P1D0373, P1D0374, P1D0374, P1D0398, P1D1350, P1D1351, P1D1351, P1D1352, P1D1413, P1D1414, P1D1422, P1D1423, P1D1423, P1D1424, P1D1510, P1D1511, P1D1511, P1E1311, P1E1379, P1E1379, P1E1380, P1E1381, P1E1382, P1E1382, P1E1383, P1E1383, P1E1507, P1E1508, P1F1020, P1F1020, P1F1021, P1F1021, P1F1022, P1F1390, P1F1390, P1F1522, P1F1522, P1F1523, P1F1524, P1G0146, P1G0146, P1G0158, P1G0158, P1G0159, P1G1114, P1G1115, P1G1116, P1G1116, P1G1122, P1G1133, P1G1134, P1G1366, P1G1367, P1H0054, P1H0054, P1H0055, P1H0056, P1H0057, P1H1296, P1H1296, P1H1297, P1H1298, P1H1298, P1J0662, P1J0664, P1J0664, P1J0727, P1J0727, P1J0896, P1J0896, P1J1260, P1J1260, P1J1261, P1J1261, P1J1273, P1J1274, P1J1344, P1J1345, P1K0354, P1K0354, P1K0355, P1K0359, P1K0359, P1K0456, P1K0456, P1K0471, P1K0471, P1K0507, P1K0507, P1L0924, P1L0925, P1M0061, P1M0062, P1M0063, P1M0067, P1M0067, P1M0068, P1M0635, P1M0636, P1M0835, P1M0837, P1M0967, P1M0968, P2A0013, P2A0014, P2A0015, P2A0016, P2A0609, P2A0610, P2A0780, P2B0134, P2B0134, P2B0534, P2B0535, P2B0535, P2B0564, P2B0564, P2B0566, P2B0566, P2B0748, P2B0748, P2B0749, P2B0988, P2C0184, P2C0184, P2C0185, P2C0186, P2C0225, P2C0225, P2C0226, P2C0226, P2C0227, P2C0227, P2C0228, P2C0228, P2C0684, P2C0766, P2C0766, P2C0767, P2C0768, P2C0880, P2C0881, P2D0034, P2D0034, P2D0035, P2D0035, P2D0036, P2D0036, P2D0037, P2D0348, P2D0348, P2D0349, P2D0733, P2D0734, P2D0735, P2F0140, P2F0141, P2F0487, P2F0495, P2F0496, P2F0496, P2F0497, P2F0498, P2F0499, P2F0499, P2G0266, P2G0534, P2G0534, P2G0535, P2G0535, P2H0040, P2H0040, P2H0041, P2H0042, P2H0042, P2H0043, P2H0043, P2H0143, P2H0143, P2H0144, P2H0144, P2H0145, P2H0146, P2H0146, P2H0412, P2H0412, P2H0413, P2H0425, P2H0426, P2H0426, P2H0582, P2H0585, P2H0586, P2J0026, P2J0027, P2J0028, P2J0028, P2J0029, P2J0030, P2J0030, P2J0084, P2J0084, P2J0085, P2J0085, P2J0086, P2J0287, P2J0287, P2J0288, P2J0330, P2J0330, P2J0444, P2J0444, P2J0445, P2J0451, P2J0451, P2J0452, P2J0453, P2J0453, P2J0454, P2K0129, P2K0129, P2K0130, P2K0130, P2K0150, P2K0381, P2K0382, P2K0383, P2K0436, P2K0437, P2K0438, P2K0439, P2K0445, P2K0445, P2K0446, P2K0446, P2K0568, P2K0568, P2K0569, P2L0094, P2L0099, P2L0100, P2L0108, P2L0264, P2L0268, P2L0416, P2L0416, P2L0417, P2L0417, P2L0418, P2L0420, P2L0421, P2L0422, P2L0423, P2L0423, P2L0424, P2L0424, P2L0425, P2L0426, P2M0028, P2M0029, P2M0030, P2M0275, P2M0421, P3A0206, P3A0241, P3A0241, P3A0242, P3B0042, P3B0042, P3B0072, P3B0232, P3B0233, P3B0233, P3B0234, P3B0309, P3B0310, P3B0440, P3B0440, P3B0441, P3B0442, P3B0518, P3B0519, P3C0315, P3C0316, P3C0342, P3C0475, P3C0476, P3C0477, P3C0516, P3C0517, P3D0252, P3D0252, P3D0253, P3D0345, P3D0345, P3D0346, P3D0346, P3D0347, P3D0347, P3D0348, P3D0348, P3E0372, P3F0070, P3F0071, P3F0072, P3F0247, P3F0247, P3F0248, P3F0574, P3F0574, P3F0575, P3F0575, P3H0832, P3H0833, P3H0834, P3H0835, P3H0835, P3H0836, P3H0837, P3H0837, P3H0838, P3H1101, P3H1102, P3H1103, P3H1103, P3H1174, P3H1175, P3H1176, P3J0866, P3J0867, P3J0867, P3J0947, P3J0947, P3J0948, P3J0948, P3K0949, P3K0950, P3K1064, P3K1064, P3K1065, P3K1065, P3K1260, P3K1260, P3K1261, P3K1355, P3K1356, P3K1356, P3K1357, P3K1358, P3K1358, P3L0675, P3L0891, P3L0892;