Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Reason for recall: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Quantity: 1,682,351 units Lot/code info: Catalog No. Catalog #, 0007-67, 0091-69, 0210-70, 0302-82, 0349-78, 0365-75, 0437-38, 0680-74, 0693-66, 0781-63, 0815-68, 0880-41, 0888-69, 0900-28, 0938-60, 0956-69, 0995-82, 10008-16, 10014-63, 10014-64, 10019-15, 10027-12, 10066-19, 10101-16, 10101-17, 10101-18, 10101-20, 10166-16, 10214-17, 10214-19, 10222-21, 10222-22, 10223-16, 10223-17, 10223-18, 10264-15, 10275-17, 10308-11, 10342-17, 10356-15, 10421-28, 10477-20, 10482-15, 10557-11, 10557-12, 10558-11, 10558-12, 10568-13, 10572-19, 10575-17, 10594-14, 10632-20, 10638-27, 10731-20, 10735-21, 10772-34, 10782-28, 10804-17, 10825-17, 10835-20, 1084-67, 10868-18, 10872-14, 10875-22, 1087-67, 1087-69, 10881-19, 10911-12, 10999-16, 11022-08, 11052-13, 11106-12, 11124-19, 11147-18, 11162-38, 11162-39, 1119-82, 11211-25, 11212-18, 11212-19, 11225-12, 11225-13, 11230-25, 11230-26, 11254-32, 11254-33, 11288-16, 11328-16, 11367-20, 11367-21, 11367-23, 11371-20, 11401-13, 11413-12, 11413-14, 11416-12, 11421-11, 11426-24, 11444-27, 11466-21, 11484-17, 11492-21, 11492-22, 11497-12, 11525-16, 11526-18, 11544-13, 11574-23, 11580-11, 1161-67, 11624-12, 11625-13, 11660-15, 11703-08, 11706-13, 11724-29, 11732-16, 11736-15, 11739-14, 11741-12, 11775-15, 11775-16, 11775-17, 11776-19, 11777-16, 1179-46, 11802-08, 11810-15, 11828-14, 11854-14, 11854-15, 11855-16, 11855-17, 11865-25, 11888-17, 11892-20, 11899-05, 11910-30, 11910-31, 11910-32, 11912-26, 11915-16, 11915-17, 1192-67, 11938-12, 11958-08, 11994-15, 12001-09, 12034-21, 12034-22, 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.