Covidien, LP: Medical Device Recall in 2024 - (Recall #: Z-1465-2024)

Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

Class II

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

Product Number/CFN: OMS-T10SB; UDI/DI: 20884521081083 and 10884521081086; Lot Serial Number: P0B1097Y, P0L1408, P0L1408, P0L1442, P0L1442, P0M1720, P0M1721, P0M1931, P1A1469, P1A1469, P1A1470, P1A1485, P1A1486, P1A1486, P1B1294, P1B1294, P1B1449, P1C0441, P1C1565, P1C1565, P1C1566, P1C1568, P1C1674, P1C1674, P1C1675, P1C1676, P1C1676, P1C1786, P1C1920, P1D0366, P1D1379, P1D1379, P1D1380, P1D1380, P1D1509, P1D1509, P1E1551, P1F1389, P1F1482, P1F1482, P1F1521, P1G0143, P1G0143, P1K0808, P1K0808, P1K1036, P1K1099, P1K1099, P1K1320, P1L0482, P1L0482, P1L0486, P1L0486, P1L0679, P1L0679, P1L0680, P1L0680, P1L0885, P1L0885, P1L1108, P1L1109, P1L1109, P1M0032, P1M0032, P1M0033, P1M0033, P2A0611, P2A0611, P2A0612, P2A0612, P2A0613, P2A0613, P2A0614, P2A0615, P2A0615, P2B0280, P2B0280, P2C0455, P2C0456, P2C0457, P2C0745, P2C0745, P2D0324, P2D0325, P2D0325, P2D0326, P2D0327, P2D0352, P2D0352, P2D0353, P2D0353, P2E0013, P2E0013, P2E0014, P2E0014, P2E0076, P2E0077, P2E0077, P2E0078, P2E0352, P2E0447, P2E0448, P2E0449, P2E0449, P2F0136, P2F0136, P2F0137, P2F0137, P2F0138, P2F0139, P2F0139, P2F0384, P2F0384, P2F0455, P2F0455, P2F0456, P2F0456, P2F0457, P2F0457, P2G0324, P2G0324, P2H0044, P2H0273, P2H0307, P2H0414, P2J0025, P2J0083, P2J0286, P2J0455, P2K0149, P2K0440, P2L0090, P2L0091, P2L0091, P2M0031, P3A0237, P3A0238, P3A0239, P3A0240, P3A0240, P3B0308, P3B0443, P3B0444, P3B0444, P3D0349, P3D0350, P3D0350, P3E0080, P3E0080, P3E0371, P3E0458, P3E0458, P3F0043, P3F0043, P3F0044, P3H0831, P3H1177, P3H1177, P3J0865, P3J0865, P3J0944, P3J0944, P3J0945, P3J0945, P3J0946, P3J1063, P3J1064, P3J1131, P3L0678, P3L0679, P3L0820, P3L0821;

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.;

Voluntary: Firm initiated