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

Recall details

Manufacturer

Covidien, LP

Distributor

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.;

Lot

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;

Risk classification

Class II

Area (FDA)

device

Country

United States