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: 87,839 units Lot/code info: Catalog No. 8065000133, 8065000134, 8065000138, 8065000139, 8065752192, 8065752193, 8065752200, 8065752201, 8065752202, 8065752203, 8065752216, 8065752217, 8065752245, 8065752917, 8065752918, 8065753134, 8065753135, 8065753136, 8065753159; Product Code 100241014, 100241015, 100241019, 100241020, 100055107, 100055110, 100009955, 100009963, 100009964, 100009965, 100009960, 100009961, 100010766, 100056645, 100055945, 100207171, 100207170, 100208838, 100208338; UDI-DI: 380650001337, 380650001344, 380650001382, 380650001399, 380657521920, 380657521937, 380657522002, 380657522019, 380657522026, 380657522033, 380657522163, 380657522170, 380657522453, 380657529179, 380657529186, 380657531349, 380657531356, 380657531363, 380657531592; Lots 14WW1F, 14WW1H, 14WW1J, 14X6CN, 14X6CP, 14X6CR, 14X6CT, 14X6CU, 14X6CV, 14XPE9, 14XPEA, 14XPEC, 14XPED, 14XPEE, 14XPEF, 14XPEH, 14Y8C2, 14Y8C3, 14Y8C4, 14Y8C5, 14Y8C6, 14Y8C7, 14YLMF, 14YLMH, 14YLMJ, 14YLMK, 14YLML, 14YLMM, 14YLMN, 14YLMP, 14YXHY, 14YXJ0, 14YXJ1, 14YXJ3, 14YXJ4, 14YXJ5, 14YXJ6, 14YXJ7, 150HDA, 150HDC, 150HDD, 150HDE, 150HDF, 150HDH, 150HDJ, 150HDK, 150HDL, 150HDM, 150HDN, 150HDP, 150HDR, 151V90, 151V91, 151V92, 151V93, 151V94, 151V95, 151V96, 151V97, 152F5H, 152F5K, 152F5L, 152F5M, 152F5N, 152F5P, 152F5R, 152F5T, 152F5V, 152F5W, 152F5X, 1539WP, 1539WR, 1539WT, 1539WU, 1539WV, 1539WW, 1539WX, 1539WY, 1540J9, 1540JA, 1540JC, 1540JD, 1540JE, 1540JF, 1540JH, 1540JJ, 1547AV, 1547AW, 1547AX, 1547AY, 1547C0, 1547C1, 1547C2, 1547C3, 1547C4,
380650001337, 380650001344, 380650001382, 380650001399, 380657521920, 380657521937, 380657522002, 380657522019, 380657522026, 380657522033, 380657522163, 380657522170, 380657522453, 380657529179, 380657529186, 380657531349, 380657531356, 380657531363, 380657531592
Official record: FDA (Device enforcement) ↗
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