Z-2230-2011

Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF...

Name: Z-2230-2011 Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF...
Creator: Deroyal Industries, Inc. Lafollette
Published: 2011-02-07
License: https://open.fda.gov/license/

Deroyal Industries, Inc. Lafollette / initiated 2011-02-07 / Terminated

FDA source

Deroyal Industries, Inc. Lafollette began a recall of Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med... on 2011-02-07. The reason FDA records is "Custom surgical kits contained either one or more of the following possible contaminated recalled products: Triad lubricating jelly, alcohol prep pads, and alcohol swabs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2230-2011
Status: Terminated
Initiated: 2011-02-07
Posted: 2011-05-20
Terminated: 2014-08-06
Recalling firm: Deroyal Industries, Inc. Lafollette
Product: Kits and Trays containing lubricant: GEO-MED BASIC CYSTO PACK, V A CENTRAL PLAINS HEALTH NET, REF 50-13272.05, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO PACK PGYBK, V A MED CTR COLUMBIA, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VAMC-NORTHPORT, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED GU TUR BASIN SET PGYBK, V A MED CTR BAY PINES - C, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED CYSTO HYDRO II PACK, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; GEO-MED ORTHO PACK A&B, VA MEDICAL CENTER - BRONX, Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) CARDIOVASCULAR DRAPE, MERITCARE HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, ST. MARY'SMED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) MAJOR CYSTO TRAY, BRYAN LGH MED CENTER EAST, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) URETHRAGRAM TRAY 20/CS, NORTH MISSISSIPPI MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PELVIC EXAM TRAY, BAPTIST MEMORIAL OXFORD, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TUR PACK PGYBK 5/CS, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LABOR AND DELIVERY TRACECART (R), KEESLER MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) PHASE ONE DELIVERY TRACECART, TALLAHASSEE MEM REGNL CTR-AMT, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO PACK, HOLLAND COMMUNITY HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) GU MINOR, MIDDLESEX MEMORIAL HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, ST ANTHONYS HOSPITAL, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) T V H TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LTC/LAP TRAY, PHOEBE PUTNEY MEM HOSP, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) LAP GYN TRAY, COFFEE REGIONAL MED CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) RADICAL PROST TRAY PGYBK, HAYS MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) D&C GYN PACK, HIGH POINTE SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CRYO TRAY PGYBK, MIDTOWN SURG CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, HOUSTON MEDICAL CTR, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CYSTO TRAY, UNIV ARKANSAS MED LITTLE ROCK, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, In
Product code: LRP Tray, Surgical
Reason for recall: Custom surgical kits contained either one or more of the following possible contaminated recalled products: Triad lubricating jelly, alcohol prep pads, and alcohol swabs.
FDA root cause: Other
Action: DeRoyal notified their consignees by letter with the subject line "Re: DeRoyal Recall of Triad Medical Lubricating Jelly, Alcohol Prep Pads and Alcohol Swabs" on 02/07/2011 that kits in their possession contained recalled Triad products that were possibly contaminated. Customers were to use the attached spreadsheet to identify and quarantine the affected product. The spreadsheet should have been completed even if there was no affected product. The form should have been faxed back to 865-362-3716 or emailed to [email protected]. Customers' DeRoyal Sales Representative would re-label the affected product in order to prevent further use. The DeRoyal Sales Representatives are also providing in-service training on effectuating this recall, including the importance of identifying, retrieving and discarding the recalled products as well as the documentation necessary to account for these products. Distributors were directed to recall down to the retail level. If there are questions or if further assistance is needed, customers can contact their DeRoyal Sales Representative or customer support department at 1-800-251-9864.
Quantity in commerce: 340,976 units total
Distribution: Nationwide Distribution
Product codes and lots: REF 50-13272.05; Lot Numbers: 17739282, 18176434, 18472233, 18812517, 19020546, 19187135, 19516744, 20175043, 20429998, 20494394, 20886460, 22346424, 22730047, 22821900, 23335313, 23615260, 24004698, 24338081; REF 89-5721.02; Lot Numbers: 17637745, 18026233, 18026241, 18081398, 18120801, 18120836, 18137363, 18179580, 18270594, 18336750, 18692682, 19052599, 19520209, 19684545, 19703890, 20210291, 20561454, 20893416, 21412776, 21559479, 22188024, 23002893, 23340948, 23534654, 23951183, 24294226; REF 89-6353.03; Lot Numbers: 16174769, 16174793, 16174806, 16407833, 18271167, 18410809, 18497262, 18639208, 18661122, 18867024, 19103261, 20501056, 21186406, 21652702, 22059951, 22124741, 22736713, 23699328, 24075699, 24233677, 24868171; REF 89-6425.03; Lot Numbers: 19569432, 19569459, 19569467, 19623929, 19686014, 19686022, 20502260, 20683970, 20895518, 21113186, 21375258, 21653650, 22021363, 22060434, 22188585, 22319101, 22437431, 22737661, 22924175, 23427461, 23623083, 23880590, 24010895, 24162493, 24578659, 24750594, 24827723; REF 89-6428.01; Lot Numbers: 16808282, 18591611, 18867534, 18966006, 19685476, 20013925, 20040771, 20179255, 20501427, 20894777, 21112933, 21653019, 22020889, 22083361, 22188323, 22506272, 22737020, 23235996, 23535711, 24076018, 24294955, 24578341, 24600617, 24776524; REF 89-6431.03; Lot Numbers: 17885503, 18146825, 18271491, 18411051, 19521041, 19685661, 19778242, 19824819, 20133118, 20179360, 20683460, 21058973, 21375178, 21653297, 22021110, 22188446, 22437246, 22590021, 22737273, 22965031, 23236180, 23236198, 24076237, 24162160, 24600692, 24827230; REF 50-12770.12; Lot Numbers: 17679267, 18007518, 18078455, 18104844, 18495216, 18810706, 19018489, 19186749, 19568595, 19673598, 19727656, 19776191, 20006637, 20173700, 20884270, 21053081, 21529018, 21813019, 21881433, 21978198, 22203811, 22286821, 22412612, 22582822, 22609440, 22821601, 23945445, 24229150, 24427324, 24745082, 25022978; REF 50-13049.13; Lot Numbers: 17634000, 17879841, 18495689, 18812365, 19900463, 20231404, 21054315, 21530211, 21645502, 22082107, 22261957, 22729986, 23198435, 23419488, 23777947, 24428845, 24853981; REF 50-5297.12; Lot Numbers: 17434198, 17902941, 18075895, 18183116, 18408725, 18452056, 18496729, 18496737, 18677440, 19023739, 19419805, 19496704, 19681168, 19901562, 20176901, 20232423, 20678855, 20890573, 21513260, 21648922, 21923568, 22018201, 22082828, 22586858, 22822451, 22938892, 23233202, 23422521, 23532552, 23838199, 24073247, 24158304, 24431770, 24575976, 24854916; REF 50-8069.03; Lot Number 17701102; REF 50-9269.02; Lot Numbers: 17374463, 18108933, 18217259, 18405153, 18495005, 18856691, 19412419, 19672253, 20283909; REF 50-9329.21; Lot Numbers: 18910336, 19023851, 19419987, 19681715, 19828861, 19869970, 20011356, 20232491, 20461154, 20679014, 20758054, 22610547, 22757282, 22822486, 22872547, 23422679, 23532683, 24369064, 24576047, 24775329, 24806789; REF 53-1930.01; Lot Numbers: 24884461, 25014468, 25015428, 25055227; REF 53-1736.06; Lot Numbers: 18118058, 18118066, 18118074, 18272995, 18273015, 18273023, 18339678, 18339686, 18339694, 18421006, 18421014, 18421022, 18539830, 18539848, 18564509, 18564517, 18564525, 18656438, 18656446, 18782004, 18782012, 18782021, 18871023, 18871031, 18871040, 18871058, 18969944, 18969952, 19030736; REF 89-0882.10; Lot Numbers: 17964092, 18074788, 18273912, 18341073, 18405188, 18676631, 19447902, 19672333, 19800294, 20230920, 20882573, 21003711, 21109267, 21314981, 21528058, 21642011, 22231475, 22788783; REF 89-2156.07; Lot Numbers: 17901420, 18074796, 18217304, 18273921, 18495072, 18533551, 18657094, 18809078, 19016707, 19412591, 20004720, 20036924, 20172942, 20491214, 20911928, 21109312, 21642070, 21861408, 22392981, 22727358, 22937611, 23416332, 23775790, 24002393, 24517709; REF 89-2422.11; Lot Numbers: 17615714, 18049857, 18217312, 18341137, 18495099, 18586302, 18809094, 19186474, 19412603, 19672413, 20004771, 20369948, 21052248, 21812331, 21861432, 22013646, 22034877, 22081788, 22581774, 22937638, 23416359, 24287093, 24426410; REF 89-2670.12; Lot Numbers: 17913404, 18214998, 18553674, 18861263, 19068751, 19417181, 19828342, 20008958, 20494968, 21054729, 21385860, 21530641, 21814521, 22140864, 22394012, 22636931, 23055274, 23335727, 23778270, 23873939, 24156296, 24356044, 24429477, 24795389; REF 89-2671.14; Lot Numbers: 17880340, 18176565, 18215000, 18451467, 18620478, 18861271, 19068769, 19187338, 19322405, 19417199, 19676254, 19777004, 20008966, 20231931, 20675911, 20712890, 20782118, 20887155, 20912390, 21004490, 21297552, 22016311, 22394021, 22730637, 22871501, 23188333, 23420008, 23470865, 23693778, 24230329, 24518971, 24662105; REF 89-2688.08; Lot Numbers: 17347676, 18183440, 18474301, 18497019, 18815751, 19044222, 19325825, 19642513, 19881493, 20011751, 21005370, 21457907, 21649597, 22058721, 22100969, 22347101, 24576477; REF 89-2817.07; Lot Numbers: 17964519, 18029725, 18183511, 18183520, 18712743; REF 89-3064.07; Lot Numbers: 17463167, 17617699, 18183909, 18342439, 18474212, 18712567, 19325649, 19881354, 20208781, 21005302, 21056919, 24102984, 24650825; REF 89-3129.02; Lot Numbers: 21649431, 21875543, 22177165, 22347048, 22624308; REF 89-3145.10; Lot Numbers: 17901489, 17974266, 18181524, 18283766, 18405241, 18469878, 18553033, 18586361, 18907831, 18977549, 19050219, 19150578, 19336621, 19447937, 19479058, 19514554, 19672499, 19810038, 19876838, 20204756, 20491329, 20537665, 20672015, 20818504, 20882805, 20954240, 21052299, 21143852, 21182907, 21421138, 21469924, 21642176, 22013718, 22013726, 22122666, 22260954, 22377001, 22434150, 22581871, 22727471, 22780571, 22917725, 23222255, 23416455, 23527817, 23775896, 24002529, 24287165, 24426495, 24572695, 24744274, 24896913; REF 89-3251.08; Lot Number 18008035; REF 89-3179.01; Lot Numbers: 17663337, 17880518, 18176725; REF 89-3423.03; Lot Numbers: 17348273, 17617912, 17643336, 18474431, 19196509, 19326001, 19683147, 20392777, 20498651, 21005425, 21319281, 22018789, 22399454, 24243859; REF 89-3448.03; Lot Numbers: 17481461, 17877520, 18135499, 18349606, 18406252, 18587014, 18858697, 18951841, 19050753, 19414289, 19751875; REF 89-3802.04; Lot Numbers: 17904399, 17904401, 18014081; REF 89-3805.12; Lot Numbers: 17739493, 17780568, 17841906, 17989038, 18456348, 18475240; REF 89-3825.13; Lot Numbers: 17779698, 17988481, 18025821, 18080070, 18177146, 18269219, 18335482, 19021776, 19101311, 19131633, 19322915, 19715410, 20009361, 20325638; REF 89-3861.10; Lot Numbers: 16404894, 17635168, 18861861, 19322958, 20207252, 21004705, 21055115, 24932241; REF 89-4260.08; Lot Numbers: 19022103, 19323344, 19337851, 19517501, 19677142, 20009598, 21647065, 22244452, 22346678, 22981364, 23066571, 23230626, 23779272, 24072076, 24519202, 24575001, 24854457; REF 89-4272.03; Lot Numbers: 17635467, 18155668, 18177550, 18473113, 18862135, 19225402, 20495952, 21947156, 22057665, 22585311, 24006061, 24290903; REF 89-4340.02; Lot Numbers: 17881351, 18177605, 18384760, 18473201, 18559961; REF 89-4401.01; Lot Numbers: 6514997, 17349170; REF 89-4431.04; Lot Numbers: 17477631, 17672209, 17802106, 18029320, 18181778, 18274000, 18525593, 18535484, 18535492, 18659209, 18862266, 19022322, 19101581, 19418263, 19517755, 19801385, 19915761, 20009791, 20207746, 20370498, 20496226; REF 89-4811.07; Lot Numbers: 18474829, 18864595, 19326490, 19519224, 20177858, 20499232, 20758492, 21057541, 21816834, 22019221, 22187638, 22216275, 22414079, 22470708, 22734718, 22922209, 23234256, 23620165, 23950383, 24025641, 24074178, 24253942, 24293338; REF 89-5197.01; Lot Numbers: 15836855, 18178552, 18473949, 19383451, 19518299, 20010492, 21338713, 21686777, 21840084, 22058393, 22732464, 22872230, 23015504, 23189424, 23258987, 23337685, 23532026, 23948777; REF 89-5434.03; Lot Numbers: 17964711, 18077401, 18185912, 18343247, 18691268, 18857029, 19017013, 19318756, 19514722, 19877048, 20491492, 20883111, 21315221, 21642504, 21837133, 22377191, 22917987, 23222651, 23690825.23944784, 24287333, 24517848; REF 89-5579.02; Lot Numbers: 17905623, 18001298; REF 89-5645.01; Lot Numbers: 17857991, 18475531, 18816964, 19120900, 21023957, 21599147, 21651582, 21817263, 21841360, 22059530, 23066985; REF 89-5702.01; Lot Numbers: 17882978, 18179184, 18475670, 18911144, 19026121, 19214851, 19327425; REF 89-5747.04; Lot Numbers: 17883330, 17989476, 18137241, 18270471, 18410104, 18410112, 18536891, 18660496, 18817473, 18896001, 19032969, 19033321, 19033339, 19033347, 19033355; REF 89-5753.03; Lot Numbers: 17781051, 17931549, 18081283, 18137275, 18179432, 18336602, 18475944, 18817529, 18896010; REF 89-5907.01; Lot Numbers: 15560924, 15817321; REF 89-5952.02; Lot Numbers: 17632012, 17679531, 17878151, 17929852, 17987358, 18078834, 18175247, 18268030, 18334316, 18406615, 18406631, 18450958, 18471370, 18534385, 18587276, 18709667, 18859180, 18931356, 19019060, 19050913, 19151642, 19248701, 19414908, 19414916, 19515856, 19878366, 20037687, 20492971, 20673923, 21004043, 21315853, 21470520, 21644235, 21921618, 22014913, 22056443, 22122965, 22272269; REF 89-6003.01; Lot Numbers: 17901761, 18013643, 18182017, 18405524, 18533841, 18857416, 19050374, 19413198, 19590557, 19672907, 19776028, 19877419, 20037206, 20378828, 20537905, 20712241, 20883509, 21052707, 21315360, 21528613, 21837361, 22055862, 22377458, 22727905, 22870509, 23066256, 23223071, 23612739, 24287632; REF 89-6060.02; Lot Numbers: 17347334, 17616119, 18315140, 18405882, 18450624, 18470676, 19050454, 19319281, 20324918, 20491919, 23417167, 23691166, 24821305; REF 89-6071.06; Lot Numbers: 17917966, 17935566, 17973925, 17973933, 18000279, 18029371, 18075300, 18217443, 18274229, 18283918, 18283926, 18341444, 18355408, 18419432, 18450472, 18657369, 19017603, 19413374, 19590581, 19751533, 20006282, 20672736, 20883648, 21109582, 21643021, 22014121, 22215563, 22315960, 22727999, 22780722, 23612835, 24153992, 24337610, 24572986, 24773753; REF 89-6169.02; Lot Numbers: 17867882, 17878813, 17878821, 18146171, 18175896, 18231325, 18334720, 18349868, 18349876, 18407010, 18471695, 18534730, 18691621, 18709991, 18859868, 18931751, 19320830, 19674540, 19800770, 19878593, 20125572, 20206161, 20517832, 20674387, 21183619, 21337340, 21813588, 22015174, 22503725, 23225253, 23418549, 23872506, 24155031, 24288678, 24518470, 24573655, 24745550, 24853649, 24897588; REF 89-6219.01; Lot Numbers: 17879058, 17879066, 17930255, 17987868, 18079255, 18136037, 18176047, 18268574, 18319351, 18334789, 18534781, 18572859, 18587858, 18638070, 18658441, 19019713, 19100837, 19415564, 19674611, 19810636, 20174403, 20493455, 20756681, 21053654, 21337358, 21529624, 21813668, 22015300, 22261711, 22729185, 22849398, 23225510, 23418696, 23692433, 24070521, 24070521, 24229627, 24573719, 24774203; REF 89-6225.03; Lot Numbers: 18176063, 18384591, 18633084, 18676957, 18710115, 19019772, 19051182, 19415610, 20007533, 20240554, 20756690, 21053697, 21529659, 21838347, 22378338, 22729231, 23872750, 24229651, 24573751; REF 89-6256.04; Lot Numbers: 17388857, 17884771, 17932023, 17990160, 18180185, 18271036, 18476613, 18537391, 18866777, 18866793, 18979544, 19027131, 19037276, 19052821, 19121232, 19188867, 19188875, 19215351, 19250430, 19328401, 19544841, 19544850, 19685089, 20132473, 20179028, 20894144, 20957424, 21112853, 21559621, 22124661, 22318597, 22589400, 22736465, 22923359, 23341457, 23621918, 24009827, 24294541; REF 89-6257.05; Lot Numbers: 17932015, 17990151, 18081873, 18137662, 18180177, 18271028, 18337162, 18350851, 18476605, 19037233, 19037241, 19103181, 19423450, 19544833, 19812156, 20132457, 20179001, 20179010, 20326809, 20379433, 20500846, 20540194, 20682539, 20801892, 21112845, 21320556, 21423141, 21458029, 21535899, 21698057, 22059847, 22110665, 22188163, 22264314, 22436913, 22589397, 22923341, 23002957, 23426012, 23535219, 23621897, 23699117, 23879142, 24009801, 24009819, 24019267, 24161546, 24311567, 24750009, 24899671; REF 89-6262.06; Lot Numbers: 17884594, 17990080, 18146817, 18215501, 18337138, 18350834, 18350842, 18410690, 18476550, 18476568, 18497238, 18537341, 18591224, 18633981, 18866726, 19027086, 19027094, 19103157, 19423361, 19481730, 19520524, 19685038, 20013546, 20178957, 20326796, 20430841, 20500791, 20894064, 20894072, 21006022, 21186289, 21305575, 21340143, 21423125, 21535830, 21652438, 21777290, 21841829, 22020512, 22020521, 22124653, 22736385, 22757451, 22822865, 23031459, 23621803, 24075411, 24233511, 24294496, 24577971, 24749972; REF 89-6406.03; Lot Numbers: 17885255, 17932226, 17990477, 18008713, 18082180, 18180610, 18271360, 18350914, 18476859, 18867438, 19027537, 19052978, 19339469, 19423935, 19456294, 19685433,20040755, 20132852, 20210806, 20410390, 20683128, 20894689, 21305701, 21652930, 21817941, 22020854, 22124813, 22318757, 22736967, 22783270, 22923682, 23235937, 23260833, 23342054, 23342054, 23426653, 23622419, 24010262, 24010262, 24075939, 24294867, 24294875, 24578296, 24631042, 24631042, 24650956, 24750295; REF 89-6727.02; Lot Number: 19956248, 20211551, 20327318, 20502673, 21585749, 21777417, 21794655, 22383022, 22924280, 23236526, 23880899, 24295544; REF 89-6564.01; Lot Numbers: 18054365, 18533294, 18585967, 18656964, 18808462, 18856165, 19016192, 19514351, 19671912, 19727541, 19876598, 20004148, 20172627, 20305071, 20490836, 20882160, 21336777, 21641659, 22315652, 22376834, 22434037, 22543639, 22780466, 22917590, 23092930, 23527340, 24286761, 24598211, 25021588; REF 89-6588.01; Lot Number 19036601; REF 89-6598.01; Lot Number 18949366; REF 89-6600.01; Lot Number 19036644; REF 89-6725.01; Lot Numbers: 19956264, 20041176, 20241098, 20502681, 21842590, 22021486, 22060506, 22590401, 22737855, 22924298, 23342978, 24162741, 24295552, 24435421, 24578771, 24827854; REF 89-6797.01; Lot Numbers: 21641392, 22055248, 22375508, 22912941, 23217721, 24064455, 24534082, 24741823; REF 89-6826.01; Lot Numbers: 21412207, 21421015, 21811769, 21836659, 22122463, 22868450, 22912932, 23217712, 23523488, 23864531, 24284642, 24570690; REF 89-6858.01; Lot Numbers: 22431477, 22483496, 22868484; REF 89-6990.01; Lot Numbers: 22244102, 22260022, 22315089, 22376009, 23218192, 23327751, 23686113, 24064914, 24284837, 24819432, 22244102, 22260022, 22315089, 22376009, 23218192, 23327751, 23686113, 24064914, 24284837, 24819432; REF 89-7063.01; Lot Numbers: 22501341, 22719366, 22914065, 23065595, 23328922, 23524739, 23772231, 23866430, 24150142, 24285362; REF 89-7257.01; Lot Numbers: 22392341, 22653715, 22838875, 22957090, 23411451, 23524448, 23607454, 24065491; REF 89-7361.0206; Lot Numbers: 22543428, 22721992, 22869111, 22959458, 23091591, 23525900, 24660556, 24820345, REF 89-7367.01; Lot Numbers: 22502159, 22914911, 23608967, 23867555, 24150871, 24253299; REF 89-7395.04; Lot Numbers: 22801010, 22822929, 23031934, 23236690, 23308569, 23390523, 23623542, 23785251, 24295659, 24855564; REF 89-7429.01; Lot Numbers: 22563146, 22581256, 22723197, 22916095, 23065843, 23220680, 23689082, 24067621, 24286226, 24743482; REF 89-7502.01; Lot Numbers: 22543487, 22635015, 22722303, 22915738, 23027927, 23525993, 23868478; REF: 89-7655.01; Lot Numbers: 24828152, 24833701; REF 94-0268.07: Lot Numbers: 17723310, 17913535, 18269833, 18319757, 18473720, 18862733, 19131721, 19418802, 19480497, 19811225, 19828570, 20409073, 20496744, 20677991, 20889353, 21184742, 21318122, 21338553, 21350683, 21839930, 21923091, 22058238, 22262757, 22317279, 22585986, 22637926, 22732245, 22800130, 23232138, 23531808, 23695343, 23948591, 24006562, 24157635, 24430662, 24575360, 24662586, 24823079; REF 94-0270.06: Lot Numbers: 17152001, 17348329, 18184282, 18621201, 19326692, 19683868, 19715891, 19829222, 19829231, 20539724, 20680971, 20724575, 21350860, 21412661, 21422843, 21697951, 22347304, 22394995, 22436366, 22964353, 23234467, 23424332, 23533942, 24160244, 24243883, 24433177; REF 47-621.08: Lot Number 15408121; REF 50-12772.13: Lot Numbers: 17901315, 18029178, 18074729, 18181364, 18217208, 18283715, 18632946, 18780113, 18908658, 19068312, 19140185, 19248487, 19414457, 19496165, 19673820, 19900041, 20124895, 20492671, 20492680, 20580701, 20627290, 20801737, 20835611, 20884456, 20932850, 20978604, 21109890, 21643881, 22412647, 22412655, 22636368, 22728633, 22821643, 22849355, 23224293, 23333810, 23691861, 24003450, 24070046, 24229299, 24427527, 24427535, 24573381, 24745218, 24853526, 24923061, 25023153; REF 50-10479.10: Lot Number: 17680313, 18214349, 18734441, 18860439, 19541683, 19675198

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)