Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

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

Code information: Product Number/CFN: OMS-T10BTS; UDI/DI: 20884521081076, 10884521081079; Lot Serial Number: P1D1416, P1E1509, P1F1547, P1H0898, P1J0874, P1J0895, P1J0895, P1J1268, P1J1268, P1J1340, P1J1340, P1J1341, P1K0181, P1L0683, P1L0978, P1L0984, P1L0984, P2A0017, P2A0017, P2A0018, P2A0019, P2A0019, P2A0020, P2A0021, P2A0021, P2A0750, P2A0750, P2B0135, P2B0136, P2B0136, P2B0752, P2B0916, P2C0757, P2D0347, P2D0541, P2D0542, P2F0385, P2F0386, P2F0386, P2H0022, P2H0022, P2H0147, P2H0147, P2K0433, P2K0433, P2K0434, P2K0434, P3D0123, P3D0123, P3D0124, P3D0124, P3E0187, P3E0187, P3E0188, P3E0189, P3E0189, P3H1197, P3J0771, P3J0858, P3K1341;

Distribution pattern: 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.;