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Covidien, LP Recall 94131

Description: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT

Covidien, LP Recall 94131 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1470-2024
Event ID94131
Event DescriptionCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Product TypeDevices
DistributionWorldwide 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.;
Quantity165,356 units
Recall ReasonThe potential for trocar seal disengagement when using mesh products incorrectly with the device.
Device Classification20240410
Device Code InfoProduct 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 Date20240403
Recall Initiation Date20240228
Recalling FirmCovidien, LP
Initial Notification Letter
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