Covidien, LP Recall 94131
Description: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Covidien, LP Recall 94131 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1470-2024 |
| Event ID | 94131 |
| Event Description | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT |
| Product Type | Devices |
| Distribution | 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.; |
| Quantity | 165,356 units |
| Recall Reason | The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| Device Classification | 20240410 |
| Device Code Info | Product Number/CFN: OMS-T10BT; UDI/DI: 10884521080874, 20884521080871; Lot Serial Number: P1D1353, P1D1353, P1D1355, P1D1409, P1D1410, P1D1506, P1D1506, P1D1507, P1D1507, P1E1402, P1E1402, P1E1403, P1E1403, P1E1505, P1E1505, P1E1506, P1E1506, P1F0061, P1F0061, P1F0062, P1F0062, P1F0063, P1F1018, P1F1018, P1F1019, P1F1388, P1F1388, P1F1546, P1G0140, P1G0140, P1G1117, P1G1117, P1G1119, P1G1119, P1G1121, P1G1121, P1G1364, P1G1364, P1H0049, P1H0049, P1H0421, P1H0527Q, P1H0527Q, P1H0859, P1H0859, P1H0860, P1H0860, P1J1272, P1J1321, P1J1321, P1J1339, P1J1339, P1J1342, P1J1342, P1K0179, P1K0179, P1K0180, P1K0180, P1K0182, P1K0182, P1K0353, P1K0353, P1K0560, P1K0560, P1K0561, P1K0561, P1K0589, P1K0589, P1L0490, P1L0490, P1L0681, P1L0681, P1L0705, P1L0705, P1L0976, P1L0976, P1M0021, P1M0021, P1M0022, P1M0744, P1M0744, P1M0745, P1M0970, P1M0971, P1M1151, P1M1152, P2A0118, P2A0118, P2B0028Q, P2B0137, P2B0137, P2B0139, P2B0139, P2B0308, P2B0745, P2B0745, P2B0912, P2B0912, P2B0913, P2B0913, P2C0175, P2C0175, P2C0178, P2C0643, P2C0643, P2C0758, P2C0758, P2C0764, P2C0765, P2C0765, P2C0877, P2C0877, P2C0878, P2C0878, P2D0231, P2D0231, P2D0232, P2D0232, P2D0373, P2D0373, P2D0374, P2D0374, P2D0415, P2D0415, P2D0539, P2D0539, P2D0540, P2D0540, P2E0244, P2E0244, P2E0245, P2E0371, P2E0371, P2F0041, P2F0041, P2F0042, P2F0133, P2F0133, P2F0134, P2F0134, P2F0135, P2F0135, P2F0449, P2F0449, P2F0450, P2F0450, P2F0451, P2F0451, P2F0452, P2F0452, P2F0453, P2F0453, P2F0454, P2F0454, P2G0141Q, P2G0533, P2G0533, P2H0085, P2H0085, P2H0142, P2H0142, P2H0419, P2H0419, P2H0570, P2H0570, P2J0081, P2J0081, P2J0362, P2J0362, P2J0442, P2J0442, P2J0443, P2J0443, P2J0460, P2J0460, P2K0080, P2K0080, P2K0123, P2K0123, P2K0432, P2K0432, P2K0565, P2K0565, P2L0554, P2L0554, P2L0555, P2L0555, P2L0556, P2L0556, P2M0032, P2M0408, P2M0408, P2M0409, P2M0410, P2M0410, P2M0411, P2M0411, P3A0084, P3A0084, P3A0085, P3A0086, P3A0086, P3A0087, P3A0271, P3A0271, P3A0272, P3A0272, P3A0273, P3A0273, P3A0277, P3A0277, P3A0278, P3A0278, P3A0279, P3A0279, P3B0075, P3B0075, P3B0147, P3B0147, P3B0158, P3B0158, P3B0162Q, P3D0121, P3D0121, P3D0122, P3D0122, P3D0150, P3D0150, P3D0151, P3D0151, P3D0152, P3D0152, P3D0399, P3D0400, P3D0400, P3D0401, P3D0401, P3E0294, P3E0294, P3E0295, P3E0295, P3E0315, P3E0315, P3E0369, P3E0369, P3F0461, P3F0461, P3F0462, P3F0462, P3H1033, P3H1033, P3H1034, P3H1193, P3H1193, P3H1194, P3H1194, P3H1195, P3H1195, P3J0855, P3J0855, P3J0856, P3J0857, P3J0857, P3J1100, P3J1100, P3J1101, P3J1101, P3J1102, P3J1103, P3J1103, P3K0951, P3K1067, P3K1068, P3K1069, P3K1243, P3K1244, P3K1339, P3K1340, P3L0889, P3L0890; |
| Center Classification Date | 20240403 |
| Recall Initiation Date | 20240228 |
| Recalling Firm | Covidien, LP |
| Initial Notification | Letter |
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