Covidien, LP: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL

Hazard

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

Details from the source

Reason for recall: The potential for trocar seal disengagement when using mesh products incorrectly with the device. 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, Mac Quantity: 11,796 units Lot/code info: 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;

UPC codes

10884521539648

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.