Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
FDA Recall #Z-1467-2024 — Class II — February 28, 2024
Product Description
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
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
11,796 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-T10BTSNL; UDI/DI: 10884521539648; Lot Serial Number: P0M1930, P1C1684, P1C1685, P1D1418, P1F1548, P1F1549, P1J0729, P1J1343, P1K0356, P1M0969, P2A0779, P2B0758, P2D0021, P2D0022, P2D0023, P2F0324, P2H0410, P2H0411, P2J0053, P2J0456, P2L0093, P2M0416, P2M0417, P3C0354, P3E0462;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated