Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
FDA Recall #Z-1465-2024 — Class II — February 28, 2024
Product Description
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
Reason for Recall
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Recalling Firm
Covidien, LP — North Haven, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
124,863 units
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.;
Code Information
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated