Alcon Research, LTD. Recall 92698
Description: Centurion FMS Pak
Alcon Research, LTD. Recall 92698 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2407-2023 |
| Event ID | 92698 |
| Event Description | Centurion FMS Pak |
| Product Type | Devices |
| 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, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, French Guayana, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Fed., Saint Martin, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, USA, USVI, Utd. Arab Emir., Uzbekistan, Vietnam, and Yemen. |
| Quantity | 87,839 units |
| Recall Reason | Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. |
| Device Classification | 20230823 |
| Device 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, 1547C5, 1547C6, 1547C7, 1547C8, 1547C9, 154YDE, 154YDF, 154YDH, 154YDJ, 154YDK, 154YDL, 154YDM, 154YDN, 154YDP, 154YDR, 155HJP, 155HJR, 155HJT, 155HJU, 155HJV, 155HJW, 1565PX, 1565PY, 1565R0, 1565R1, 1565R2, 1571HV, 1571HW, 1571HX, 1571HY, 1571J0, 1571J1, 1571J2, 1571J3, 1571J4, 1571J5, 1571J6, 157DN2, 157DN3, 157DTR, 157DTT, 157DTU, 157DTW, 157DU2, 157DU4, 157DU5, 157DU6, 157DU7, 157DU8, 157DU9, 158CXM, 158CXN, 158CXP, 158CXR, 158CXT, 158CXU, 158CXV, 158CXW, 158CXX, 158CXY, 158VLV, 158VLW, 158VLX, 158VLY, 158VM0, 158VM1, 158VM2, 158VM3, 1599H3, 1599H4, 1599H5, 1599H6, 1599H7, 1599H8, 1599HF, 1599HH, 1599HJ, 1599HK, 1599HL, 1599HM, 1599HN, 1599HP, 1599HT, 159PPH, 159PPJ, 159PPK, 159PPL, 159PPM, 159PPN, 159PPP, 159PPR, 159PPT, 159PPU, 159PPV, 159PPW, 159PPX, 159PPY, 159PR0, 159PR1, 15A8H0, 15A8H2, 15A8H3, 15A8H4, 15A8H5, 15A8H6, 15A8H7, 15A8H8, 15A8H9, 15A8HA, 15A8HC, 15A8HD, 15A8HE, 15A8HF, 15A8HH, 15A8HJ, 15AV8Y, 15AV90, 15AV91, 15AV92, 15AV93, 15AV94, 15C9UU, 15C9UV, 15C9UW, 15C9UX, 15C9UY, 15C9V0, 15CRV8, 15CRV9, 15CRVA, 15CRVC, 15CRVD, 15CRVE, 15CRVF, 15CRVH, 15CRVJ, 15CRVK, 15CRVL, 15CRVM, 15CRVN, 15CRVP, 15D86V, 15D86W, 15D86X, 15D86Y, 15D870, 15D871, 15DRRV, 15DRRW, 15DRRX, 15DRRY, 15DRT0, 15DRT1, 15DRT2, 15E7KD, 15E7KE, 15E7KF, 15E7KH, 15E7KJ, 15E7KK, 15ET22, 15ET23, 15ET24, 15ET25, 15ET26, 15ET27, 15F8J1, 15F8J3, 15F8J4, 15H004, 15H005, 15H006, 15H007, 15H008, 15HK4E, 15HK4F, 15HK4H, 15HK4J, 15HK4K, 15HK4L, 15HK4M, 15J10N, 15J10V, 15J116, 15JPYK, 15JPYL, 15JPYM, 15JPYP, 15JPYR, 15JPYT, 15KYKE, 15KYKH, 15LTWU, 15LTX0, 15LTX1, 15M91N, 15M91Y, 15M923, 15M928, 15METN, 15METP, 15PX3M, 14WW1L, 14WW1M, 14WW1R, 14WW1T, 14X6CY, 14X6D0, 14X6D2, 14X6D3, 14X6D4, 14X6D5, 14X6D6, 14XPEJ, 14XPEK, 14XPEL, 14XPEM, 14XPEN, 14XPEP, 14XPER, 14XPET, 14XPEU, 14Y8CA, 14Y8CC, 14Y8CE, 14Y8CF, 14Y8CH, 14Y8CK, 14Y8CL, 14YLMT, 14YLMU, 14YLMV, 14YLMW, 14YLMX, 14YLMY, 14YLN0, 14YLN1, 14YLN2, 14YLN3, 14YXJ8, 14YXJ9, 14YXJA, 14YXJC, 14YXJD, 14YXJE, 14YXJF, 14YXJH, 14YXJJ, 14YXJK, 14YXJL, 150HDV, 150HDW, 150HDX, 150HDY, 150HE0, 150HE1, 150HE2, 150HE3, 150HE4, 150HE6, 151VAD, 151VAE, 151VAF, 151VAH, 151VAJ, 151VAK, 151VAL, 152F60, 152F61, 152F62, 152F63, 152F64, 152F65, 152F66, 1539X0, 1539X1, 1539X2, 1539X3, 1539X4, 1539X5, 1539X6, 1539X7, 1540JN, 1540JP, 1540JR, 1540JT, 1540JV, 1540JW, 1540JX, 1540JY, 1547CF, 1547CH, 1547CJ, 1547CK, 1547CL, 1547CM, 1547CN, 1547CP, 154YDT, 154YDU, 155HJY, 155HK0, 155HK1, 155HK2, 155HK3, 1565R6, 1565R7, 1565R8, 1565R9, 1571JA, 1571JC, 1571JD, 1571JE, 1571JF, 1571JH, 1571JJ, 1571JK, 1571JL, 1571JN, 1571JP, 157DWT, 157DWV, 157DWX, 157DWY, 157DX1, 157DX3, 157DX5, 157DX7, 157DX9, 157DXC, 157DXE, 158CY0, 158CY1, 158CY2, 158CY3, 158CY4, 158CY5, 158CY6, 158CY7, 158CY8, 158CY9, 158CYA, 158VM4, 158VM5, 158VM6, 158VM7, 158VM8, 158VM9, 158VMA, 158VMC, 1599JL, 1599JM, 1599JN, 1599JP, 1599JT, 1599JU, 1599LK, 1599LL, 1599LM, 1599LN, 1599LP, 1599LR, 1599LT, 1599LU, 1599LV, 1599LW, 159PR5, 159PR6, 159PR7, 159PR8, 159PR9, 159PRA, 159PRC, 159PRD, 159PRE, 159PRF, 159PRH, 159PRJ, 159PRK, 159PRL, 159PRM, 159PRN, 15A8HM, 15A8HN, 15A8HP, 15A8HR, 15A8HT, 15A8HU, 15A8HV, 15A8HW, 15A8HX, 15A8HY, 15A8J0, 15A8J1, 15A8J2, 15A8J3, 15A8J4, 15A8J5, 15AV97, 15AV98, 15AV99, 15AV9A, 15C9V2, 15C9V3, 15C9V4, 15C9V5, 15CRWF, 15CRWH, 15CRWJ, 15CRWK, 15CRWL, 15CRWM, 15CRWN, 15CRWP, 15CRWR, 15CRWT, 15D87D, 15D87E, 15D87F, 15D87H, 15F8J5, 15F8JA, 15F8JM, 15F8JU, 15F8JV, 15H009, 15H00A, 15H00C, 15H00D, 15H00E, 15HK4N, 15HK4P, 15HK4R, 15HK4T, 15HK4U, 15HK4V, 15HK4W, 15HK4X, 15J12H, 15J12L, 15J12P, 15J12V, 15J130, 15J134, 15J135, 15J136, 15JR05, 15JR06, 15JR07, 15JR08, 15JR09, 15JR0A, 15JR0C, 15JR0D, 15KYKN, 15KYKP, 15KYKR, 15KYKT, 15LU00, 15LU01, 15M92C, 15M92D, 15M92E, 15M92H, 15M92J, 15M92K, 15M92L, 15M92M, 15METX, 15MEU0, 15MEU1, 14WW1V, 14WW1W, 14X6D7, 14X6D8, 14X6D9, 14X6DA, 14XPEW, 14XPEX, 14XPEY, 14XPF0, 14Y8CP, 14Y8CT, 14Y8CU, 14YLPR, 14YLPT, 14YLPU, 14YXJP, 14YXJR, 14YXJT, 14YXJU, 150HE9, 150HEA, 150HEC, 150HED, 150HEE, 151VC3, 151VC4, 151VC5, 151VC6, 151VC7, 151VC8, 152F6R, 1539XF, 1539XH, 1539XJ, 1540K0, 1540K1, 1540K2, 1547CW, 1547CY, 1547D0, 1547D1, 1547D2, 155HK5, 155HK6, 1565RC, 1565RD, 1565RE, 1565RF, 1565RH, 156X16, 156X17, 156X18, 156X1D, 1571JU, 1571JV, 1571JW, 157DY8, 157DYA, 158VMF, 158VMH, 158VMJ, 158VMK, 1599M2, 1599M3, 1599M4, 1599M5, 1599M6, 1599M7, 1599M8, 1599M9, 1599MA, 159PRP, 159PRR, 15A8J6, 15A8J7, 15A8J8, 15A8J9, 15A8JA, 15A8JC, 15A8JD, 15A8JE, 15D87W, 15D87X, 15D87Y, 15D880, 15DRTC, 15DRTD, 15E7KL, 15E7KM, 15E7KN, 15E7KP, 15E7KR, 15ET28, 15ET29, 15ET2A, 15ET2C, 15ET2D, 15ET2E, 15F8KN, 15F8KP, 15H01Y, 15H020, 15H021, 15KYL9, 15KYLA, 15KYLC, 15LU03, 15LU06, 15LU07, 15MEU9, 15MEUA, 15MEUD, 14X6DC, 14X6DE, 14XPF5, 14XPF7, 14XPF8, 14Y8E9, 14Y8EA, 14YLPX, 14YLPY, 14YLR0, 14YLR1, 150HEF, 150HEH, 150HEJ, 151VC9, 151VCA, 152F6U, 1539XK, 1540K3, 155HK7, 1565RJ, 1565RK, 1565RL, 1565RM, 1571JX, 1571JY, 157M7P, 158VML, 158VMM, 1599MC, 1599MD, 1599ME, 1599MF, 159PRT, 15A8JH, 15A8JJ, 15A8JL, 15A8JM, 15A8JN, 15A8JP, 15A8JR, 15A8JT, 15D883, 15D884, 15E7KW, 15E7KX, 15E7KY, 15E7L0, 15H022, 15KYLD, 15KYLE, 15MEUH, 15PWXF, 14XPAM, 14XPAN, 14XPAP, 150HA2, 150HA3, 151V6V, 151V6W, 152F44, 1539TX, 1539U0, 155HFY, 157LXH, 157LXJ, 158VL8, 159PMX, 159PMY, 15C9NH, 15D858, 15D859, 15DRPK, 15DRPL, 15DRPM, 15DRPN, 15F8CV, 15FYY0, 15KYJ4, 15LTVJ, 14Y8AK, 14Y8AL, 14YLLU, 150HAK, 150HAT, 151V6X, 151V6Y, 152F45, 1539XU, 1539XV, 1540H0, 155HHN, 155HHP, 1565JW, 1577YD, 157LXK, 157LXM, 157LXN, 158VL9, 159PN2, 159PN5, 15CRNT, 15CRNV, 15CRNY, 15CRP1, 15D85C, 15D85D, 15DRPR, 15ET09, 15F8D3, 15FYY4, 158419, 14WW0H, 14WW0J, 14WW0K, 14WW0P, 14WW0R, 14X6A9, 14X6AA, 14X6AC, 14X6AD, 14X6AE, 14XPAV, 14XPAW, 14XPAX, 14Y8AM, 14Y8AN, 14YLLV, 14YLLW, 14YXF2, 14YXF3, 14YXF4, 150HAV, 150HAW, 150HAX, 150HAY, 150HC0, 150HC1, 150HC2, 150HC3, 150HC4, 150HC5, 150HC6, 150HC7, 150HCH, 150HCJ, 150HCK, 150HCM, 151V70, 151V71, 151V72, 151V73, 151V74, 152F48, 152F49, 152F4A, 152F4C, 152F4D, 152F4E, 152F4F, 152F4J, 152F4L, 152F4N, 152F4P, 1539U2, 1539U3, 1539U4, 1539U5, 1539U6, 1539U7, 1539U8, 1539U9, 1539UA, 154YD5, 154YD6, 154YD7, 154YD8, 154YD9, 154YDA, 154YDC, 154YDD, 155HJ7, 155HJ8, 155HJ9, 155HJA, 155HJC, 1565KA, 1565KD, 1565KF, 1565KJ, 1565KL, 1565KM, 157LXR, 157LXT, 157LXU, 157LXV, 157LXX, 157LXY, 15840X, 15840Y, 158415, 158416, 158418, 158419, 1585WV, 1585WW, 1585WX, 1585WY, 1585X0, 1585X1, 158CV1, 158CV2, 158CV3, 158CV4, 158CV5, 158CV6, 158CV7, 158CV8, 158CV9, 158CVA, 158VLC, 158VLD, 158VLE, 15AV8J, 15AV8K, 15AV8L, 15AV8M, 15AV8P, 15C9NL, 15C9NM, 15C9NN, 15C9NP, 15C9NR, 15C9NT, 15C9NU, 15C9NV, 15CRPC, 15CRPE, 15CRPF, 15CRPV, 15CRPX, 15CRPY, 15CRR0, 15D85P, 15D85R, 15D85T, 15D85U, 15D85V, 15D85W, 15D85X, 15DRPT, 15DRPU, 15DRPV, 15DRPW, 15DRPX, 15DRPY, 15E7JU, 15E7JV, 15E7JW, 15E7JY, 15E7K0, 15E7K1, 15ET0A, 15ET0C, 15ET0D, 15ET0E, 15ET0F, 15ET0H, 15ET0J, 15F8D5, 15F8D6, 15F8D7, 15F8D9, 15FYY5, 15FYY6, 15FYY7, 15FYY8, 15FYY9, 15HK3Y, 15HK40, 15HK41, 15HK42, 15HK43, 15HK44, 15J0Y6, 15J0Y7, 15JPXU, 15JPXX, 15KYJ9, 15LTW5, 15LTWC, 14WW0V, 14WW0W, 14WW0X, 14WW17, 14XPAY, 14XPC0, 14XPC1, 14XPC2, 14XPC3, 14XPC4, 14XPC5, 14Y8AP, 14Y8AR, 14Y8AT, 14Y8AU, 14Y8AV, 14YLLX, 14YLLY, 14YLM0, 14YLM1, 14YLM2, 14YLM3, 14YLM4, 14YLM5, 14YXF5, 14YXF6, 14YXF7, 14YXF8, 14YXF9, 14YXFA, 14YXFC, 150HCN, 150HCP, 150HCR, 150HCT, 150HCU, 150HCV, 150HCW, 150HCX, 150HCY, 150HD0, 151V76, 151V77, 151V7D, 151V7E, 151V7F, 154YE4, 154YE5, 154YE6, 154YE7, 154YE8, 155HJE, 155HJF, 155HJH, 155HJJ, 155HJK, 1565L8, 1565L9, 1565LA, 1565LD, 1565LF, 1565LJ, 157M7L, 15841A, 15841C, 15841D, 15841E, 15841F, 15841H, 15841J, 15841K, 1585X3, 1585X4, 1585X5, 1585X6, 1585X8, 1585X9, 1585XD, 1585XE, 158CVD, 158CVE, 158CVF, 158CVH, 158CVJ, 158CVK, 158CVL, 158CVM, 158VLF, 158VLH, 158VLJ, 15AV8R, 15AV8T, 15AV8U, 15AV8V, 15C9P7, 15C9P8, 15C9P9, 15C9PA, 15CRT1, 15CRT6, 15CRT7, 15CRTE, 15CRTJ, 15CRTL, 15CRTN, 15D861, 15D862, 15D863, 15D864, 15D865, 15D866, 15D867, 15D868, 15D869, 15DRR3, 15DRR4, 15DRR5, 15DRR6, 15DRR7, 15DRR8, 15DRR9, 15DRRA, 15DRRR, 15E7K4, 15E7K5, 15E7K6, 15E7K7, 15E7K8, 15E7K9, 15E7KC, 15ET0K, 15ET0M, 15ET0N, 15ET0P, 15ET0R, 15ET0T, 15ET0U, 15F8HN, 15F8HT, 15F8HU, 15FYYU, 15FYYV, 15HK46, 15HK47, 15HK48, 15HK49, 15JPY1, 15JPY4, 15M91F, 15M91M, 14XPCJ, 14Y8AW, 14YLMC, 150HD2, 151V7H, 1539VE, 1540H6, 155HJL, 157LY0, 157LY1, 15CRTX, 15CRU0, 15DRRP, 15F8HV, 15KYJY, 14XPCK, 14Y8AX, 14YLMD, 14YLME, 150HD3, 151V7K, 1539VY, 1540HE, 157LY4, 159PN6, 15D86N, 15D86P, 15DRRT, 15F8HW, 15FYYY, 15H000, 14X6C6, 14X6C7, 14X6C8, 14X6C9, 14X6CA, 14X6CC, 14X6CD, 14YXH8, 14YXH9, 14YXHA, 14YXHC, 14YXHD, 14YXHE, 14YXHF, 151V89, 151V8A, 151V8C, 151V8D, 151V8E, 1540HJ, 1540HK, 1540HL, 1540HM, 1540HN, 1540HP, 1540HR, 1540HT, 1540HU, 1540HV, 1565NE, 1565NH, 1565NK, 1565NL, 1565NN, 1565NR, 1583W8, 1583W9, 1583WC, 159PNE, 159PNF, 159PNH, 15CRUV, 15CRUW, 15CRUX, 15CRUY, 15CRV0, 15ET1K, 15ET1L, 15ET1N, 15J0YX, 15J100, 15J101, 15J107, 15J108, 15J109, 15LTY8, 15LTYA, 14X6CE, 14X6CF, 14X6CH, 14X6CJ, 14X6CK, 14X6CL, 14X6CM, 14YXHJ, 14YXHK, 14YXHL, 14YXHM, 14YXHN, 14YXHP, 14YXHR, 14YXHT, 151V8F, 151V8H, 151V8J, 151V8K, 151V8L, 151V8M, 1540HW, 1540HX, 1540HY, 1540J0, 1540J1, 1540J2, 1540J3, 1540J4, 1565P7, 1565P9, 1565PA, 1565PD, 1565PF, 1565PH, 1565PK, 1565PL, 15840V, 15840W, 159PP0, 159PP1, 159PP2, 15CRV2, 15CRV4, 15CRV5, 15CRV6, 15CRV7, 15ET1R, 15ET1T, 15ET1U, 15ET1V, 15ET1W, 15ET1X, 15ET1Y, 15ET20, 15ET21, 15J10A, 15J10C, 15J10D, 15J10J, 15LTYJ, 15LTYK, 15LTYL, 15LTYM, 150HD4, 1539WH, 1565PT, 15AV8X, 15C9PX, 14XPCM, 14Y8AY, 14Y8C0, 14YXHV, 14YXHW, 150HD5, 150HD6, 1539WJ, 1539WK, 1539WL, 1540J8, 155HJM, 1565PV, 1565PW, 157LY6, 158VLU, 15C9R5, 15D86R, 15D86T, 15F8HX, 15H001, 15H002, 15JPYC, 15JPYE, 14XPE8, 14Y8C1, 150HD7, 151V8W, 1539WM, 1539WN, 155HJN, 157LY8, 15F8HY, 1545JX, 1565JK, 1585WM, 1585WR, 15AV9F, 15D885, 15H023, 15H024, 1585WT, 151PR4. |
| Center Classification Date | 20230816 |
| Recall Initiation Date | 20230628 |
| Recalling Firm | Alcon Research, LTD. |
| Initial Notification | Letter |
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