Alcon Research, LTD. recalls Infinity FMS Pak

Hazard / Issue

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Catalog No. 8065741085, 8065750280, 8065750281, 8065752086, 8065752087, 8065752090, 8065752093, 8065752094, 8065752095, 8065752096; Product Code 100003158, 100004405, 100055054, 100009758, 100009094, 100009370, 100009098, 100009099, 100009100, 100009101; UDI-DI: 380657410859, 380657502806, 380657502813, 380657520862, 380657520879, 380657520909, 380657520930, 380657520947, 380657520954, 380657520961; Lots 154532, 1571CW, 1571CX, 150374, 14WCPD, 150374, 151J41, 151J42, 152H82, 152W36, 1598PY, 1598R0, 159LH6, 1571D2, 1598RA, 14YLLD, 14YLLE, 150FF5, 150FF6, 151J5W, 1532WH, 153JT7, 155LTD, 1571DK, 1571DL, 1571DM, 1571DN, 1571DP, 1571DR, 1571DT, 1571DU, 15A6MW, 15A6MX, 15C330, 15C331, 15C333, 15C334, 15D42R, 15DH93, 15EL09, 154539, 156751, 156752, 156755, 156756, 14VCLK, 14VCLL, 14VCLM, 14XPL9, 14XPLA, 14Y62U, 14Y62V, 15037P, 15037R, 15037T, 150FEL, 150FEM, 150FEN, 150FEP, 150FER, 150FET, 150FEU, 150FEV, 150FEW, 150FFX, 1532XL, 1532XU, 1532Y0, 1532Y5, 1532YC, 1532YE, 153JT8, 153JT9, 153JTA, 153JTC, 155LTE, 155LTF, 155Y8L, 155Y8M, 156D81, 156D82, 156D83, 156D84, 156D85, 156D86, 15A6MY, 15A6N0, 15C335, 15C336, 15C337, 15C338, 15CJJC, 15CJJE, 15CJJJ, 15CJJK, 15D42Y, 15D430, 15D437, 15D438, 15D439, 15D43A, 15D43C, 15DH9A, 15DH9P, 15DH9R, 15DH9U, 15DH9X, 14YXXD, 15EMYW, 1571E4, 1571E9, 153JTK, 158M7M, 158M7N, 151VEY, 153JTL, 1571EA, 158M7R.