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U.S. Department of Health and Human Services

Class 2 Device Recall Meter Remote for OneTouch Ping Glucose Management System

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  Class 2 Device Recall Meter Remote for OneTouch Ping Glucose Management System see related information
Date Initiated by Firm October 27, 2008
Date Posted March 03, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-0955-2009
Recall Event ID 50796
510(K)Number K080639  
Product Classification Insulin Infusion Pump - Product Code LZG
Product Meter Remote for OneTouch Ping Glucose Management System
Code Information Serial numbers: AAXNN080, AAXND08J, AAXNC00X, AAXNN06Q, AAXNP09T, AAXNK07H, AAXND00C, AAXNN01J, AAXNQ04F, AAXNS0CK, AAXNT01D, AAXLR02G, AAXNC07G, AAXNH01W, AAXNK01X, AAXNL07N, AAXNQ023, AAXNS07W, AAXNR082, AAXNR089, AAXND093, AAXNM033, AAXNL07T, AAXNF06Z, AAXNF020, AAXNQ080, AAXNR07Z, AAXNK0B5, AAXND002, AAXNP05R, AAXNP093, AAXLR00W, AAXNC038, AAXNF05B, AAXNM04K, AAXNN02W, AAXNS0BN, AAXNL03P, AAXLR022, AAXNL01N, AAXNL09X, AAXNS07S, AAXNB04K, AAXNS02H, AAXND023, AAXNF010, AAXNK027, AAXNL09B, AAXNM04H, AAXNR04T, AAXNN08M, AAXNK01R, AAXLR03X, AAXNP04H, AAXNF0BB, AAXNK055, AAXNK084, AAXNN061, AAXNS0C5, AAXND056, AAXNM026, AAXNN07N, AAXLR04T, AAXNC03F, AAXND04T, AAXNL00S, AAXNL05L, AAXNN056, AAXNP0B4, AAXNT02T, AAXPS03L, AAXNL04L, AAXNL036, AAXNK00W, AAXNK006, AAXNC067, AAXNL04C, AAXNR048, AAXNR017, AAXNS00H, AAXNG0C5, AAXNF02Z, AAXNB01Q, AAXNF02G, AAXJW04Z, AAXNB0B3, AAXNQ016, AAXNJ01S, AAXJW071, AAXNF016, AAXNM05S, AAXNQ002, AAXNH016, AAXNB02P, AAXND064, AAXLR039, 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AAXNH03S, AAXNH072, AAXND01W, AAXNB03D, AAXND028, AAXNK0BQ, AAXNP01R, AAXNB09X, AAXNQ027, AAXNR008, AAXNB023, AAXNS08N, AAXPP03W, AAXNC027, AAXNH031, AAXNB08V, AAXNG0B2, AAXLP01M, AAXLR04H, AAXNK0CZ, AAXND04K, AAXNS09F, AAXNN00H, AAXNM035, AAXLQ05V, AAXPS05Q, AAXNS07J, AAXNH05M, AAXNM05W, AAXNJ023, AAXNQ003, AAXLP027, AAXNF04R, AAXNS09H, AAXNG0C1, AAXNQ094, AAXNL032, AAXNR0CD, AAXNB047, AAXNC03X, AAXNB08F, AAXNS018, AAXNT00W, AAXND03C, AAXNT00Z, AAXNN03Q, AAXNR02G, AAXNN06G, AAXLP013, AAXJW07N, AAXNR025, AAXLP00D, AAXNH0CK, AAXND09P, AAXNG057, AAXNL04J, AAXNR04X, AAXNC078, AAXNQ039, AAXNB03L, AAXNF05S, AAXNH034, AAXNL08V, AAXNP05W, AAXPR049, AAXNP02F, AAXNC07F, AAXND06J, AAXND086, AAXNS0B7, AAXNC03R, AAXLR02N, AAXPZ00B, AAXNL01H, AAXNM064, AAXNR00V, AAXNH00T, AAXNQ07B, AAXNC072, AAXNB078, AAXNV01G, AAXNK00N, AAXND05W, AAXNM04D, AAXPP030, AAXNG071, AAXJW04V, AAXLQ068, AAXNG037, AAXNG096 AAXNK00K, AAXNL07L, AAXNL06L, AAXNG0BH, AAXNC005, AAXND08V, AAXNP05T, AAXNL03X, AAXNR085, AAXNN027, AAXNB03G, AAXNC05F, AAXNF075, AAXNL07J, AAXNR098, AAXNR0BV, AAXND05R, AAXNL00L, AAXNR045, AAXNR07V, AAXPP00F, AAXPS095, AAXNB03T, AAXNK00T, AAXNL05D, AAXPP028, AAXNB05L, AAXNK058, AAXLR02M, AAXND01P, AAXNG05V, AAXNG0B9, AAXNH04G, AAXNC059, AAXNK0B3, AAXNK0CG, AAXMZ0D1, AAXNJ073, AAXNR0BS, AAXNM020, AAXNS01L, AAXNB088, AAXNN02B, AAXNN02V, AAXNR06Z, AAXPP07G, AAXNN04P, AAXNP006, AAXNN05H, AAXND05P, AAXNF02R, AAXNC06J, AAXJW05M, AAXNS03P, AAXNK0CJ, AAXNL01F, AAXNQ009, AAXLR025, AAXNL044, AAXNB04X, AAXNP09G, AAXJW077, AAXNF038, AAXNL01W, AAXNM06P, AAXND0B1, AAXNN05M, AAXNN068, AAXNK08L, AAXPQ016, AAXJW07C, AAXNL03H, AAXNL04N, AAXNV059, AAXLQ02G, AAXNB02F, AAXNB06L, AAXNB087, AAXNF006, AAXNG043, AAXNL055, AAXNL077, AAXNQ04N, AAXNR05K, AAXPP084, AAXND03Z, AAXNQ008, AAXPS07V, AAXNF02S, AAXNG07P, AAXNP09W, AAXNR080, AAXNC08W, AAXND08P, AAXNM006, AAXNR09L, AAXNK03V, AAXNB097, AAXNJ06G, AAXNC04P, AAXNK02T, AAXNK00G, AAXNN03R, AAXNL08X, AAXNN04M, AAXPS048, AAXNN07M, AAXNP0B3, AAXND07H, AAXNG04X, AAXNP0B5, AAXNG084, AAXNL07B, AAXNC061, AAXNM05R, AAXPR00V, AAXND022, AAXNN05N, AAXLS002, AAXNG00F, AAXNR06W, AAXNC01H, AAXNL05T, AAXND021, AAXNR036, AAXNC05R, AAXNR034, AAXJW06S, AAXLR056, AAXNB072, AAXNC03P, AAXNC09S, AAXNG022, AAXNL065, AAXNQ04B AAXNR026, AAXNR04B, AAXNS07M, AAXNN01M, AAXNP005, AAXNS0CB, AAXNB0BB, AAXLP008, AAXND059, AAXNF08D, AAXNG00Q, AAXNN082, AAXNR044, AAXPP04N, AAXNF030, AAXNH01V, AAXNS067, AAXNG05K, AAXNC05K, AAXNQ05R, AAXLR027, AAXNB074, AAXJW06Z, AAXLQ05Q, AAXNN03M, AAXNC077, AAXNT014, AAXNF070, AAXNN045, AAXNC020, AAXNG055, AAXNP06G, AAXND07G, AAXLP01D, AAXNC065, AAXNK00P, AAXLR02V, AAXND07L, AAXJW072, AAXND03P, AAXNN01D, AAXNJ07V, AAXNL00W, AAXNL002, AAXND02T, AAXNG0C7, AAXLR037, AAXNL01J, AAXPR02Q, AAXND099, AAXNK09H, AAXNK02X, AAXPR05S, AAXNN052, AAXNG081, AAXNK08N, AAXNL079, AAXNN07W, AAXPR04R, AAXLP00F, AAXNR08D, AAXNF05V, AAXNH06F, AAXNN07T, AAXNR04G, AAXPR04H, AAXPP00L, AAXNG030, AAXNM01H, AAXNR06L, AAXJX004, AAXNR08M, AAXNB05R, AAXND09F, AAXNB06B, AAXNC02W, AAXNC0B2, AAXNK00V, AAXNM040, AAXNQ01H, AAXNR02H, AAXNR04H, AAXNP00Q, AAXNH08H, AAXNM01N, AAXNP01X, AAXPP01J, AAXNC04V, AAXNB03V, AAXNB07L, AAXNN024, AAXNT02Z, AAXND014, AAXND07Z, AAXNS05X, AAXNN06H, AAXNB080, AAXNM021, AAXPP086, AAXNF05R, AAXNM00C, AAXNS01Q, AAXJW05J, AAXNB034, AAXPP03Q, AAXND00F, AAXND068, AAXNF00B, AAXNL006, AAXNN01T, AAXNR069, AAXPS089, AAXJW04Q, AAXNB071, AAXPS097, AAXND09Z, AAXNK01J, AAXNQ075, AAXNG05W, AAXNH06R, AAXNN05L, AAXNK013, AAXND036, AAXNP06D, AAXNK0D6, AAXNP01D, AAXNB04W, AAXNP07J, AAXPP00Z, AAXNG086, AAXNP0B7, AAXNL005, AAXNS01M, AAXNL00Z, AAXND02F, AAXNK09G, AAXNH03Z, AAXJW07B, AAXNF04M, AAXNB016, AAXNK05J, AAXNC062, AAXNK0BB, AAXNF06K AAXNS08C, AAXNB02V, AAXNL04P, AAXND09N, AAXNF06T, AAXNR057, AAXNS08R, AAXNJ026, AAXNQ00H, AAXNQ00X, AAXNC01T, AAXNG007, AAXNC024, AAXNK0CV, AAXNQ05L, AAXNR0BB, AAXLP029, AAXNG02D, AAXNC058, AAXNM03S, AAXNF01M, AAXNJ06F, AAXNK04K, AAXNN01X, AAXJW054, AAXNF04Q, AAXNN04H, AAXNN033, AAXNB03B, AAXNM005, AAXNB06N, AAXNL08R, AAXPP06T, AAXPS09G, AAXNC003, AAXNF039, AAXNG00D, AAXNH00P, AAXNR04Z, AAXNC06H, AAXPS03M, AAXNR09B, AAXNN00V, AAXNH00D, AAXNC02R, AAXNH086, AAXNN02G, AAXPS09K, AAXND07F, AAXNL09G, AAXNR038, AAXND03W, AAXNK014, AAXNB09C, AAXNS01Z, AAXNK09B, AAXNM05J, AAXNS0BB, AAXNK042, AAXND08M, AAXNG02C, AAXNP09V, AAXNB09J, AAXNC04M, AAXNG05G, AAXND0B2, AAXNK003, AAXNL06V, AAXNK07T, AAXNC01L, AAXNB03N, AAXNR018, AAXND071, AAXNN022, AAXJW050, AAXLS003, AAXNH067, AAXNP026, AAXNB086, AAXNJ06B, AAXNC00D, AAXNS0BD, AAXNF06V, AAXNH012, AAXNH06Z, AAXNK085, AAXNK096, AAXNL03D, AAXNR04N, AAXNS013, AAXNB03R, AAXLQ028, AAXND04C, AAXNB025, AAXNM06D, AAXNB066, AAXNC051, AAXND09X, AAXNF08Z, AAXNG0BK, AAXNM03N, AAXNP00K, AAXJW08Q, AAXNH056, AAXNM062, AAXLQ035, AAXNQ01R, AAXNS084, AAXNV05L, AAXNC05T, AAXNK0C3, AAXNB052, AAXNS02T, AAXNB03Q, AAXNF055, AAXNS099, AAXNC03W, AAXNM02K, AAXPP00M, AAXNJ06L, AAXNR0CH, AAXNL03Q, AAXNB05H, AAXNS0BH, AAXLQ03Z, AAXLQ05L, AAXLR00P, AAXNB01D, AAXNB05V, AAXNB08L, AAXNB0B4, AAXNC04C, AAXNF0B6, AAXNH030, AAXNH04V, AAXNH08K, AAXNK08J, AAXNL06K, AAXNL076, AAXNL09L, AAXNN00W, AAXNN03W, AAXNN08J, AAXNQ035, AAXNR043, AAXNS07N, AAXNS09R, AAXNT02P, AAXPS05N, AAXJW07L, AAXLR00H, AAXNJ04R, AAXNL05X, AAXNC06D, AAXJW059, AAXLR047, AAXNB07S, AAXNC04Z, AAXNC070, AAXNC08P, AAXND051, AAXNF013, AAXNG09C, AAXNKOBC, AAXNL07W, AAXNM011, AAXNS06C, AAXPP085, AAXNH03J, AAXNB07M, AAXNJ00Z, AAXNM00J, AAXNN074, AAXNP00F, AAXNN08Q, AAXNR05N, AAXNB029, AAXNL08Z, AAXLR053, AAXNR010, AAXNS07Q, AAXPP05C, AAXNR07Q, AAXNC03Q, AAXNQ03B, AAXNG01R, AAXNN08N, AAXNH0B0, AAXNH006, AAXPS058, AAXNQ04M, AAXNJ07L, AAXNJ04T, AAXNC07B, AAXNC07M, AAXPP01N, AAXNM04T, AAXNN02K, AAXPP055, AAXNM04B, AAXNR07G, AAXNJ01W, AAXNP08X, AAXNP072, AAXNC02N, AAXNS09G, AAXNN05V, AAXND06V, AAXNS08J, AAXPW01V, AAXNL0B3, AAXNV01H, AAXNP05N, AAXNB05W, AAXNH0BZ, AAXPS07G, AAXNK044, AAXPP05J, AAXNH00R, AAXNC02V, AAXNQ09H, AAXNF00D, AAXLR009, AAXNB09N, AAXNQ06Z, AAXPQ015, AAXLR05C, AAXNL06T, AAXNB08Q, AAXNL00P, AAXNN040, AAXJW052, AAXND02X, AAXNC006, AAXLR03M, AAXNQ05Z, AAXNL04Z, AAXLQ05B, AAXNG093, AAXLR03P, AAXNF027, AAXNR003, AAXNG02J, AAXNM055, AAXNB04F, AAXNM03B, AAXNC04X, AAXLR03C, AAXNB0B6 AAXNL08H, AAXLR03T, AAXND05H, AAXNH06D, AAXNM06B, AAXNM06Q, AAXNQ02X, AAXNF054, AAXNG04C, AAXNQ015, AAXNM01C, AAXNL048, AAXNB058, AAXLP01H, AAXNB01W, AAXND01S, AAXNG01G, AAXND074, AAXNP05V, AAXNH047, AAXNN07Z, AAXNL01D, AAXNS05P, AAXNH05F, AAXNK07L, AAXNB04C, AAXNM02R, AAXPP071, AAXND076, AAXNQ03V, AAXNH04C, AAXND04G, AAXNF06W, AAXNM004, AAXNN00R, AAXNS06Z, AAXNK09M, AAXNN06F, AAXNP09Q, AAXNF071, AAXNB05Z, AAXNK095, AAXNL007, AAXNR00D, AAXNR0BG, AAXNC08G, AAXNR08T, AAXLQ02S, AAXLR02L, AAXNB07V, AAXNB092, AAXLP01C, AAXNL06Q, AAXNB07Z, AAXNG09Q, AAXNL092, AAXNQ07R, AAXNR01F, AAXNF0B5, AAXNN066, AAXNP01B, AAXLR00N, AAXNM061, AAXLQ05J, AAXNL09M, AAXJW06V, AAXNC04R, AAXNP00L, AAXNH05V, AAXNH08G, AAXNK03X, AAXNF05J, AAXNH071, AAXNR071, AAXNG02T, AAXNS03V, AAXNP099, AAXNQ05S, AAXNG08P, AAXNN05D, AAXNQ06V, AAXNN09X, AAXNR03Q, AAXNQ061, AAXNR077, AAXLR01C, AAXNT00L, AAXNG0BX, AAXNS0BK, AAXLQ01W, AAXND06L, AAXNB031, AAXNF04V, AAXLR001, AAXNB091, AAXNB015, AAXNP082, AAXNT004, AAXNB03X, AAXNM03L, AAXNL04T, AAXNN03F, AAXNC086, AAXJW096, AAXNG082, AAXNL046, AAXNJ07X, AAXNN03D, AAXJW07X, AAXND00D, AAXNQ08S, AAXNL062, AAXNG01K, AAXMZ00S, AAXNJ07Z, AAXNM01D, AAXNB08B, AAXNS00N, AAXNL081, AAXNS06X, AAXNQ01C, AAXNP002, AAXNS008, AAXNP06L, AAXLT03T, AAXNG06D, AAXNJ04B, AAXNK0B9, AAXPR02H, AAXNQ08F, AAXNN08Z, AAXNJ05D, AAXNG077, AAXLR02S, AAXNJ07F, AAXNP07P, AAXNN00G, AAXNF009, AAXLR024, AAXNL045, AAXNF03C, AAXNQ04G, AAXNQ09T, AAXNG09W, AAXJW04P, AAXNK05B, AAXNN05T, AAXNB05J, AAXNN085, AAXNC01Q, AAXNJ07W, AAXNG00X, AAXNN03L, AAXNV00M, AAXNF09T, AAXLR03G, AAXNP018, AAXNP077, AAXNT01H, AAXNQ072, AAXLR04B, AAXNK08R, AAXNL066, AAXNN003, AAXNS089, AAXNS09S, AAXPR03N, AAXPR056, AAXNN087, AAXNP09Z, AAXND019, AAXNC039, AAXNC021, AAXNH042, AAXLR02W, AAXNL05Z, AAXND08T, AAXPP00D, AAXLR04S, AAXPP020, AAXNC02C, AAXNK00L, AAXNK056, AAXNB0BD, AAXNP04J, AAXNR0BW, AAXNS0CN, AAXNP087, AAXLQ02N, AAXPR02D, AAXNC09L, AAXPS05G, AAXNH01K, AAXNF06G, AAXLR00G, AAXNN01G, AAXNF01H, AAXNQ020, AAXNH01H, AAXNR091, AAXNL04Q, AAXNS088, AAXPR06V, AAXNC018, AAXNL06D, AAXND09B, AAXNF05H, AAXNL09T, AAXNM01Q, AAXNS020, AAXNT00K, AAXNK0CH, AAXND055, AAXNK07J, AAXPP02D, AAXNF067, AAXLP019, AAXNC03K, AAXNR0BX, AAXPS02X, AAXNS0BG, AAXNM03K, AAXND03M, AAXNG05F, AAXJW051, AAXNJ06R, AAXJW06R, AAXNB0B7, AAXLQ067, AAXNP007, AAXNP028, AAXNP08B, AAXLR010, AAXNK0B7, AAXNL008, AAXNR05V, AAXNC05J, AAXNC09Z, AAXNB069, AAXNG03G, AAXNN05Q, AAXLQ02D, AAXNC02S, AAXNB083, AAXNN039, AAXJW06F, AAXND09Q, AAXPQ058, AAXNR08H, AAXNB060, AAXNH03B, AAXNB02S, AAXNB03P, AAXNS025, AAXLP018, AAXNK039, AAXNR07D, AAXNT017, AAXND015, AAXPP02X, AAXNB03H, AAXNS00W, AAXNN02M, AAXNF06C, AAXNC028, AAXNS07Z, AAXNC05H, AAXNC06B, AAXND080, AAXNK0BW, AAXNN07J, AAXNC008, AAXNR0BJ, AAXNL05J, AAXNR05X, AAXNH09Q, AAXNQ00V, AAXNH00J, AAXNK0CW, AAXNS08D, AAXNH076, AAXNG04J, AAXLR045, AAXNN03S, AAXNG02L, AAXLR01L, AAXND039, AAXNL08D, AAXNC09G, AAXNL03L, AAXJW08C, AAXNC03L, AAXNH02T, AAXNH010, AAXNM01S, AAXNT02D, AAXLP024, AAXNK02K, AAXNR0CL, AAXNS093, AAXNJ06X, AAXNQ025, AAXNC02F, AAXNG04V, AAXNQ06R, AAXJW064, AAXNK02C, AAXNP07K, AAXNB02K, AAXNF03X, AAXNQ07J, AAXNS062, AAXJW05V, AAXLQ054, AAXLQ055, AAXNF06J, AAXNG00J, AAXNR02K, AAXPP07N, AAXNF09R, AAXNF02M, AAXNC09C, AAXNC0B3, AAXNK04T, AAXNP0B6, AAXNR08L, AAXNN00X, AAXNN069, AAXNH01Q, AAXNL00M, AAXND01R, AAXNL02N, AAXNR01L, AAXNH033, AAXPS053, AAXNN01V, AAXNK03C, AAXNH038, AAXNJ04H, AAXNB0B8, AAXNH048, AAXNN01L, AAXNN02F, AAXNP04Q, AAXNB065, AAXNK034, AAXNR05S, AAXNJ055, AAXNM06S, AAXPP05F, AAXLQ05C, AAXPP02F, AAXLR048, AAXLR005, AAXND024, AAXNQ08T, AAXNL087, AAXLQ06G, AAXNL05S, AAXNR04S, AAXPP00X, AAXNL06C, AAXNM045, AAXNH05W, AAXLR00M, AAXNG078, AAXNM008, AAXND046, AAXNG04B, AAXNR083, AAXNC06N, AAXJW04D, AAXNH00N, AAXNS085, AAXNR06P, AAXND04F, AAXNR01D, AAXNG0BD, AAXNM054, AAXNS01V, AAXJW078, AAXNC04T, AAXPP06H, AAXND04V, AAXNC029, AAXNS09K, AAXNL04W, AAXNR05Z, AAXPP07V, AAXPR03K, AAXNP004, AAXPS091, AAXNC04B, AAXPS09B, AAXNC06Z, AAXNH004, AAXNF004, AAXNB089, AAXNL09K, AAXNR06F, AAXNF00F, AAXNG08V, AAXLQ042, AAXND04B, AAXNC04K, AAXNG009, AAXNM024, AAXNK064, AAXND05J, AAXNF023, AAXJW055, AAXNL07G, AAXNQ07D, AAXNG058, AAXNK0CC, AAXNG0BL, AAXNF01W, AAXNP09S, AAXNQ01K, AAXND01Q, AAXNN07R, AAXJW05W, AAXNT02K, AAXNQ07G, AAXNR037, AAXLR02C, AAXNR03B, AAXNN07V, AAXNK0D5, AANXD098, AAXNB00C, AAXNC07W, AAXLQ063, AAXNM00T, AAXLR03V, AAXLQ05F, AAXPS03V, AAXNL042, AAXNP05Z, AAXNS01N, AAXNK01V, AAXLQ059, AAXNK02Z, AAXNF025, AAXNN02L, AAXNH087, AAXNL085, AAXNP06K, AAXNH057, AAXNL094, AAXNR01W, AAXPP08N, AAXNG080, AAXLQ04J, AAXNP016, AAXNC00P, AAXNP06P, AAXNM069, AAXNJ01R, AAXNK09D, AAXNP03P, AAXNG08C, AAXNN02T, AAXNR07J, AAXNR09N, AAXNL063, AAXNR04J, AAXNB03J, AAXNL061, AAXNM00Z, AAXNQ06F, AAXNC07K, AAXNJ07B, AAXNF09X, AAXNS051, AAXLP007, AAXLQ051, AAXJW04C, AAXLQ044, AAXLR00F, AAXLR04P, AAXNB049, 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AAXNN06K, AAXNH01G, AAXNM05X, AAXNS0C3, AAXNQ08P, AAXNB01H, AAXPP022, AAXNH06L, AAXNR023, AAXNC00H, AAXNK01S, AAXNQ08H, AAXNB09S, AAXNC019, AAXNQ064, AAXLR038, AAXNK071, AAXLP035, AAXNN08V, AAXNQ02D, AAXNP01G, AAXNC03B, AAXNK0B6, AAXNN03K, AAXNS009, AAXJW08J, AAXNM03J, AAXNJ02D, AAXNM01G, AAXNP03L, AAXNS04Q, AAXNR012, AAXNH06K, AAXNP08M, AAXNK0C6, AAXNJ056, AAXNG09Z, AAXNG06Z, AAXNF00C, AAXND04J, AAXNQ037, AAXNK059, AAXNL068, AAXNN01Q, AAXND04H, AAXND08R, AAXNH021, AAXNL00B, AAXNN05P, AAXNN09P, AAXPQ04X, AAXNN09K, AAXNN06X, AAXNN00Z, AAXNC05M, AAXNF043, AAXNK018, AAXNN063, AAXNQ02K, AAXNG02B, AAXNV00C, AAXNG067, AAXNG07V, AAXNF02K, AAXNP06F, AAXJW07Q, AAXLP026, AAXNQ04P, AAXNR06M, AAXNK083, AAXNM015, AAXNN04F, AAXNJ04V, AAXLQ030, AAXLQ05M, AAXNL07R, AAXNB06D, AAXNQ00Q, AAXNH07Z, AAXNK076, AAXNR06D, AAXNR07R, AAXNH03H, AAXNC02P, AAXLR03B, AAXNG05M, AAXLR040, AAXNT01Z, AAXLQ04F, AAXND01H, AAXNH002, AAXLQ04R, AAXNQ069, AAXLR01B, AAXNL091, AAXNQ06X, AAXNT00D, AAXNQ028, AAXNG00G, AAXND07V, 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AAXNB04P, AAXNQ00D, AAXNF048, AAXNN00Q, AAXNQ05J, AAXND09H, AAXNG054, AAXNG0BJ, AAXNS00S, AAXPQ054, AAXNH008, AAXNH01S, AAXNC0B0, AAXNH05B, AAXNL014, AAXNQ00T, AAXLP034, AAXNH043, AAXNK048, AAXNK07V, AAXLR02R, AAXND07B, AAXNG00Z, AAXNL08T, AAXNM03G, AAXNP07D, AAXNM02T, AAXNB09T, AAXND01X, AAXNB07T, AAXNH06B, AAXNK06R, AAXNL07M, AAXNQ01Q, AAXNV00F, AAXNT031, AAXNB03K, AAXNS060, AAXNK004, AAXNN09T, AAXNG02W, AAXNB07P, AAXNC002, AAXNH03D, AAXNK0BD, AAXNM032, AAXNR020, AAXPS03J, AAXND063, AAXNB018, AAXND011, AAXNK0D1, AAXNL07X, AAXNL00V, AAXNF05L, AAXNG05Z, AAXNJ080, AAXNL07H, AAXNQ00L, AAXNR05W, AAXNR08G, AAXNS017, AAXNV00J, AAXPR054, AAXLQ02J, AAXNJ022, AAXNR02L, AAXNM03V, AAXNB046, AAXNB06M, AAXND02G, AAXNN048, AAXNN07P, AAXNS00Z, AAXNS0CP, AAXJW06G, AAXNG0BR, AAXLR04L, AAXNN01F, AAXLQ02F, AAXPR061, AAXLQ065, AAXNR01Q, AAXND06P, AAXNF01F, AAXNB017, AAXNN04R, AAXNS050, AAXPP056, AAXNK007, AAXNB0BG, AAXNN08X, AAXNB07W, AAXNN07L, AAXNM06R, AAXNS0BS, AAXND07Q, AAXND09W, AAXNJ07N, AAXNL01Q, 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Recalling Firm/
Manufacturer		 Animas Corporation
200 Lawrence Dr
West Chester PA 19380
For Additional Information Contact Animas
866-423-4087
Manufacturer Reason
for Recall		 incorrect dosing recommendation
FDA Determined
Cause 2		 Software design
Action The recalling firm issued Urgent: Medical Device Correction letters dated 10/27/08 to their customers/user to inform them of the problem. The letter stated that the firm was in the process of correcting the issue and that a new OneTouch Ping Meter-Remote would be provided as soon as one became available. In the interim, customers could still safely use their OneTouch Ping System provided that they use the ezCarb calculator on the meter-remote when it is paired and communicating with the pump. The letter listed guidelines to ensure that the device is properly communicating with the pump. The letter stated that customers should follow the directions in the Owner's Booklet to troubleshoot any communication issues. Questions regarding this letter were to be directed to Animas at 866-423-4087. A patient acknowledgment letter dated November 18, 2008 was also issued. Another Urgent: Medical Device Correction letter, dated November 2008, was issued along with the replacement device. This letter asked customers to download their current meter-remote data, set up their replacement meter-remote, and then return their current meter-remote.
Quantity in Commerce 5093 units
Distribution Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = ANIMAS CORP.
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