FDAFDA · Alimentos y medicamentos·N.º oficial Z-1468-2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
Publicado el 10 de abril de 2024 · Inicio del retiro: 28 de febrero de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Covidien, LP
- Distribuidor
- 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.;
- Lote
- Product Number/CFN: OMS-T12BT; UDI/DI: 20884521081090, 10884521081093; Lot Serial Number: P1C1924, P1D0400, P1D0400, P1D1411, P1D1412, P1D1508, P1F1483, P1F1484, P1F1484, P1F1485, P1F1485, P1F1591, P1G0141, P1G0141, P1G1118, P1G1120, P1H0046, P1H0046, P1H0047, P1H0047, P1H0048, P1H0048, P1H0861, P1H0861, P1H0862, P1H0862, P1J0858, P1J0858, P1J0860, P1J0860, P1K0455, P1K0455, P1K0838, P1K1052, P1L0926, P1L0926, P1L0985, P1M0026, P1M0026, P1M0027, P1M0027, P1M0028, P1M0028, P1M0031, P1M0031, P1M0743, P1M0743, P2A0129, P2A0744, P2A0744, P2A0745, P2B0746, P2B0746, P2C0176, P2C0176, P2C0177, P2C0177, P2C0230, P2C0230, P2C0231, P2C0231, P2C0232, P2C0232, P2C0233, P2C0233, P2C0879, P2C0879, P2D0512, P2D0512, P2E0351, P2E0351, P2E0370Q, P2E0664, P2E0664, P2F0486, P2F0486, P2G0305, P2G0305, P2H0086, P2H0086, P2H0087, P2H0148, P2H0148, P2H0308, P2H0409, P2H0415, P2H0415, P2H0579, P2H0579, P2J0008, P2J0008, P2J0082, P2J0082, P2J0458, P2J0459, P2J0459, P2K0081, P2K0081, P2K0124, P2K0124, P2K0435, P2K0435, P2K0566, P2K0566, P2L0565, P2M0162, P2M0163, P2M0163, P2M0164, P2M0164, P2M0269, P2M0269, P2M0270, P2M0270, P2M0271, P2M0271, P2M0274, P2M0274, P3A0164, P3A0164, P3B0074, P3B0263Q, P3B0263Q, P3D0154, P3D0154, P3D0155, P3D0155, P3D0247, P3D0247, P3D0248, P3D0248, P3D0249, P3D0249, P3D0402, P3E0244, P3E0244, P3E0245, P3E0245, P3F0571, P3F0572, P3F0572, P3G0180, P3G0180, P3G0331, P3G0331, P3G0332, P3G0332, P3H0760, P3H0760, P3H0763, P3H0763, P3H0764, P3H1058, P3J1104, P3J1104, P3J1165, P3K1277Q, P3L0884;
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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