510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1422-2012

Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF...

Deroyal Industries, Inc. Lafollette / initiated 2012-02-07 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Deroyal Industries, Inc. Lafollette began a recall of Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by... on . The reason FDA records is "Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1422-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Deroyal Industries, Inc. Lafollette
Product
Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal KNEE ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NEURO SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal BREAST BIOPSY TRAY, REF 70-10770.05, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ANGIOGRAM TRAY-4/CASE, REF 70-1911.20, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal DIAGNOSTIC LAP BASIN, REF 89-0323.06, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PLASTICS TRAY, REF 89-1918.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal EXTREMITY TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ENT EAR TRAY, REF 89-3338.11, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal CHILD CENTRAL LINE, REF 89-3351.07, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAPAROTOMY TRAY, REF 89-3482.06, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal MINOR INTERVENTIO
Product code
KDD Kit, Surgical Instrument, Disposable
Reason for recall
Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
DeRoyal Industries sent a Recall of Episeal Wound Closure Strip letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. Please identify and quarantine any affected inventory using the product and lot numbers listed above. 2. Render affected product unusable, destroy and discard according to your facilitys guidelines. 3. If you are a distributor, forward this recall to any of your end users that may have affected product or provide us with the list and we will contact them. 4. Please complete the enclosed Notice of Destruction form, indicating the affected products you found in your inventory and destroyed. PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE THE PRODUCT IN INVENTORY. Return this form by fax (865-362-3716) or email ([email protected]) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. If you have questions or need assistance with the recall, please contact DeRoyal Customer Support at 1-800-251-9864. We apologize for inconvenience this may cause you
Quantity in commerce
42941 units distributed
Distribution
Worldwide Distribution -- USA (nationwide)
Product codes and lots
REF 47-483, Lot Numbers: 27449271, 27199769, 26706212, 25465699, 25573374, 25750861, 25043496, 24808987; REF 47-491.12, Lot Numbers: 25402954, 25313425; REF 47-626.10, Lot Numbers: 27200029, 25573420, 25465752, 25750844, 25448039; REF 47-732.03, Lot Numbers: 27449300, 26140642, 26023315, 25573876, 24525899; REF 47-787.00, Lot Numbers: 27617924, 26733317, 25574596, 25362737, 25223251; REF 50-7104.05, Lot Numbers: 27559242, 27370028, 26754601, 26136539, 25490325; REF 50-7195.12, Lot Numbers: 27488798, 26742619, 26597992, 26414922, 26314711, 26270324, 26010477, 25893511, 25608717, 25369349, 25159165, 24832987, 24741575; REF 50-9786.03, Lot Numbers: 27489150, 27181278, 26676261, 26415634, 26599445, 26367361, 25609306, 25529701, 25358172, 25369533, 25024543; REF 50-12421.10, Lot Numbers: 26115201, 25697801, 25609031; REF 50-12892.09, Lot Numbers: 27473705, 27123297, 26971008, 26743099, 26384444, 26016941, 25609066, 25490165, 25357882, 25099537, 24853913; REF 50-12898.07, Lot Numbers: 27692561, 27489395, 27181850, 26863103, 26676981, 26280709, 26018760, 25558692, 25358560, 25100198, 24898599, 24747521; REF 50-12892.09, Lot Numbers: 27855439, 27425480, 27181391, 26801375, 26394440, 26385009, 26115703, 24795522, 24662674; REF 70-10770.05, Lot Numbers: 27473713, 26278810, 26017249, 25308108, 25044931; REF 70-1911.20, Lot Numbers: 27728448, 26801084, 26497676, 26384639, 26017257, 25609314, 25358181, 25099836; REF 89-0323.06, Lot Numbers: 24746229, 24684662; REF 89-1918.07, Lot Numbers: 27609721, 27244718, 27180603, 26870768, 26813624, 26676341, 26384663, 26166771, 26017345, 25415341, 25099895, 25024631; REF 89-2176.09, Lot Numbers: 26384698, 26115439, 26062891, 25839574, 25764496, 25609381, 25358261, 25099932, 24662041; REF 89-2703.08, Lot Numbers: 27287005, 26923532, 26115973, 25610008, 25397593, 24898775, 25086031, 25100649; REF 89-2995.10, Lot Numbers: 27473756, 26840649, 25396911, 25024851, 24746421; REF 89-3053.1111 and 89-3053.10, Lot Numbers: 27890710, 27854997, 27776474, 27824528, 27750821, 27588781, 27470310, 27223482, 26839921, 26783648, 26662088, 26398053, 26015420, 25876421, 25697406, 25594693, 25529103, 25396312, 25458894, 24897393, 25272820, 25141766, 24833234, 24661604; REF 89-3190.10, Lot Numbers: 27473473, 27226667, 26956561, 26784430, 26475688, 26279100, 25697879, 25340095, 25201984, 25024957, 24746481; REF 89-3338.11, Lot Numbers: 27078369, 26980588, 26957724, 26785221, 25597034, 25086103, 24898804, 24855134; REF 89-3351.07, Lot Numbers: 27197149, 26957732, 26729289, 26437972, 26394458, 26099037, 25878830; REF 89-3452.07, Lot Numbers: 25255245, 25308204; REF 89-3472.08, Lot Numbers: 27692406, 27227336, 26368612, 24775601; REF 89-3482.06, Lot Numbers: 25086200, 25027533, 24650868; REF 89-3559.11, Lot Numbers: 27487218, 27342668, 27758487, 27286053, 26728091, 26279290, 26609877, 26125371, 25877458, 25459740, 25647396, 25415392, 25308255, 25220843, 25142291, 24898126, 24746579; REF 89-3561.09, Lot Numbers: 27826064, 27648421, 27472711, 27408621, 27342684, 27286070, 27206332, 26956705, 27100335, 26784528, 26663241, 26578679, 26398504, 26279329, 26098190, 26017759, 25816743, 25647409, 25459758, 25340271, 25273507, 25142304, 25025132, 25025124, 24774705; REF 89-3565.12 and 89-3565.13, Lot Numbers: 27610108, 27474345, 27425594, 27286942, 26801527, 27182043, 26664374, 26207931, 26063739, 25597376, 25460679, 25309063, 25203197; REF 89-3564.06, Lot Numbers: 26958129, 26610114, 26553404, 26385367, 26437999, 25879277, 25648006, 25558916; REF 89-3831.10, Lot Numbers: 27649328, 27409033, 26956799, 26922821, 26728180, 26367652, 26098245, 25340360, 25084909; REF 89-3896.07, Lot Numbers: 25340394, 25220886, 24822498, 24806720; REF 89-4003.04, Lot Numbers: 27758541, 27472884, 27498363, 27226122, 27180283, 26956852, 26345031, 26017919, 25816786, 25764576, 25596015, 25025335, 24898214, 24854393, 24774828; REF 89-4049.01, Lot Numbers: 25839700; REF 89-4087.02, Lot Numbers: 25876439, 25458923, 24915301; REF 89-4150.05, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4185.08, Lot Numbers: 25933077, 26093541, 25396347, 25083594, 25023196, 24853542; REF 89-4195.08, Lot Numbers: 27360882, 26077532, 25339174, 25121159; REF 89-4270.06, Lot Numbers: 27689629, 26955665, 26726934, 26366633, 25876501, 26097154, 26277104, 25839339, 25594749, 25697465, 25083674, 24821575; REF 89-4712.09, Lot Numbers: 24599943, 25027710, 25027728, 25143227, 25342007, 25460601, 25597237, 25698521, 25745949, 25879058, 26020026, 26281699, 26398969, 26579073, 26664251, 26785361, 27181649, 27181657, 27197157, 27286838, 27370044, 27474193, 27759076, 27869195, 27903074, 27911752; REF 89-4932.03, Lot Numbers: 27225841, 26956001, 26727321, 25876914, 25339668, 25159499; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-4990.02, Lot Numbers: 27968433, 27636050, 27473182, 27226405, 26728817, 26957370, 26648850, 26368225, 25878258, 25596533, 25558545, 25341101, 25369584, 25085557; REF 89-4955.04, Lot Numbers: 27386441, 27180056, 26987173; REF 89-5032.01, Lot Numbers: 27758292, 27244523, 27542272, 27035271, 26820613, 26985952, 26781562, 26270383, 26384057, 26166033, 26010573, 26077209, 25893562, 25873748, 25763717, 25414859, 25159202, 24741639, 24772347; REF 89-5059.01, Lot Numbers: 27892037, 27867886, 27825029, 27757759, 27741693, 27699376, 27589476, 27527355, 27527371, 27499198, 27407636, 27341446, 27285085, 27224354, 27178378, 26783031, 26800823, 26921182, 26954718, 26783023, 26725827, 26725819; REF 89-5102.03, Lot Numbers: 27700357, 26648876, 26078050, 26037910, 25866450, 25732849; REF 89-5103.03, Lot Numbers: 27648801, 27590522, 27528446, 27499260, 27310498, 27226325, 27100626, 26841078, 26663726, 26345306, 25698214, 25308511, 25142697, 24823108; REF 89-5173.01, Lot Numbers: 26821069, 26280451, 26018559, 25839849, 25698265, 25558617; REF 89-5228.07, Lot Numbers: 26764404, 26704321; REF 89-5259.05, Lot Numbers: 25142814, 25221011, 24974150; REF 89-5293.07, Lot Numbers: 27970306, 27846524, 27206586, 27182431, 26923735, 26821122, 25916736, 25817682, 25397809, 25028181, 24899217; REF 89-5341.01, Lot Numbers: 27221786, 26813472, 25893925, 25141475; REF 89-5383.04, Lot Numbers: 27697901, 27635807, 27385887, 27283397, 27310324, 27034420, 26955083, 26870602, 26726230, 26783373, 26632014, 26565296, 26226956, 26136256, 26090770, 25082946, 24820943; REF 89-5488.02, Lot Numbers: 26096813; REF 89-5545.02, Lot Numbers: 27174828, 26980668, 25879541, 25597632, 24916216, 24824653; REF 89-5559.08, Lot Numbers: 27140126, 26366246, 26726424, 25876041, 25594247, 25415077, 25022249; REF 89-5562.03, Lot Numbers: 27635831, 26986912, 26870611, 26366254, 26096848, 25916402, 25022257, 24953113, 24773690; REF 89-5565.03, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5655.01, Lot Numbers: 27930435, 27807197, 27587104, 27338706, 27488384, 27174772, 26345867, 26149495, 25698708, 25274673, 25028456, 24955371; REF 89-5657.04, Lot Numbers: 27220556, 26923815, 26369236, 26099635, 35242576; REF 89-5687.01, Lot Numbers: 27697531, 26345939, 26090921, 25597721; REF 89-5711.02, Lot Numbers: 27220652, 26958532, 26730212, 26566061, 25879681, 25840479, 25559089; REF 89-5820.01, Lot Numbers: 27467962, 27155598, 26726985, 26366668, 26062541, 25816233, 25529242, 25339246, 25099406; REF 89-5901.02, Lot Numbers: 25339220, 25307754, 25083711, 24853614; REF 89-6211.01, Lot Numbers: 27499067, 24821815; REF 89-6234.03, Lot Numbers: 27902514, 27643268, 27369668, 27175193, 26783875, 26366879, 26277585, 25697596, 25307826, 25084010, 24923192, 24598861; REF 89-6344.02, Lot Numbers: 27339371, 27175450, 26785900, 26665035, 26566117, 26651397, 26021281, 25648461, 25531676, 25398211, 25359044, 25309397, 25203816, 25143972, 24916371, 24826430; REF 89-6397.04, Lot Numbers: 27423450, 26399435, 25880171, 25598272, 25343261, 25087819, 25029766; REF 89-6478.03, Lot Numbers: 27889866, 27608964, 27525771, 27468623, 27221655, 26842450, 26730870, 26476541, 26283811, 25880454, 25648612, 25343472, 25490632, 25030071, 24750455, 24663984; REF 89-6509.01, Lot Numbers: 27339581, 26275467, 25838985, 25696921, 25557112, 25338112; REF 89-6642.03, Lot Numbers: 27787528, 27698111, 26675381, 26726686, 26344311, 25083421, 25338948, 24853446; REF 89-6671.01. Lot Numbers: 27222607, 27688896, 26100325, 26369973, 25880569, 25575919; REF 89-6724.01, Lot Numbers: 26284363, 25880737, 25294375, 25699356, 25088299, 24827838, 24750711, 24776760; REF 89-6814.03, Lot Numbers: 27902688, 27222834, 26094842, 25974215, 25777916, 25649738, 25019197, 24964568; REF 89-6816.03, Lot Numbers: 27255450, 27197026, 27176794, 26800778, 26723645, 26660058, 26394167, 26364021, 26314753, 26314745; REF 89-6830.05, Lot Numbers: 27750805, 27526782, 27340751, 27244195, 27197034, 27177367, 26952958, 26813261, 26781669, 26583700, 26061101, 26061098; REF 89-6844.02, Lot Numbers: 26364064, 26094922, 25080684, 25019234, 24922579; REF 89-6981.03, Lot Numbers: 27177375, 26836842, 26396921, 26660251, 26011120, 25080924, 24597260; REF 89-7061.01, Lot Numbers: 27757054, 27340419, 27176989, 26820656, 26660470, 26364494, 26095095, 25814959, 25592794, 25336977, 25019761; REF 89-7063.01, Lot Numbers: 27931139, 27178360, 26886276, 26820752, 26763997, 26724568, 26643186, 26565018, 26474503, 26397181, 26343722, 25748795, 25457841, 25268100; REF 89-7072.02, Lot Numbers: 27757071, 27645204, 26724242, 26396998, 26011533, 25744170, 24571140; REF 89-7112.01, Lot Numbers: 28036671; REF 89-7158.01, Lot Numbers: 27757986, 27699641, 26764041, 26725405, 26598485, 26166279, 24597964; REF 89-7449.02, Lot Numbers: 27868117, 27845505, 27868109, 27527611, 27407943, 27285376, 27224821, 26921043, 26782813, 26661157, 26674821, 26644365, 26474888, 26365526, 26114823, 26096223, 26013475, 26013467, 25875137, 25696761, 25593535, 25506833, 25395811, 25337806, 25337793, 25255000, 25021191, 25140966, 24952541; REF 89-7462.03, Lot Numbers: 27224047, 26838856, 26725528, 26365518, 26096207, 25271915, 25140958, 25021174, 25021158, 24896454, 24852902, 24820441; REF 89-7549.02, Lot Numbers: 27757732, 27471030, 26783103, 26693116, 26437817, 26275205, 26147713, 26042330, 26014048, 25875330, 25593703; REF 89-7613.01, Lot Numbers: 27868512, 27776888, 27825889, 27700111, 27758372, 27670696, 27472403, 27342473, 27285940, 27179848, 26731362, 26652429, 26370296, 26284620, 26136803, 26064416, 26022380, 26022371, 25944622, 25840831, 25765341, 25699410, 25088475, 25030804, 24649883; REF 89-7646.02, Lot Numbers: 27776896, 27656501; REF 89-7688.01, Lot Numbers: 25438130, 26097648; REF 89-7693.02, Lot Numbers: 26956166, 26922151, 26784069, 26727451, 26662635, 26662651, 26647048, 26344741, 26278123, 25647151, 26016537, 26016545, 25595389; REF 89-7758.01, Lot Numbers: 27609035, 27636826; REF 89-7871.01, Lot Numbers: 27911947, 27951818, 27962912, 28069245, 28076681; REF 89-7762.01, Lot Number: 27468981; REF 89-7768.01, Lot Numbers: 27930662, 27823701, 27469079, 27176153, 27176145; REF 89-7880.01, Lot Number: 28016899; REF 89-7896.01, Lot Number: 27993891; REF 89-6317.02, Lot Numbers: 27823269, 27525510, 27339143, 27221153, 27175222, 26842177, 26730491, 26579591, 26664981, 26498871, 26369551, 26099969, 25866581, 25818028, 25648436, 25531633, 25398182, 25203761, 25087561, 25029512, 24826384, 24750050; REF 89-6371.03, Lot Numbers: 27468463, 26958938, 26730634, 26665123, 26566150, 26369682, 25880147, 25793289, 25598256, 25029723, 24855450, 24750228; REF 89-6432.01, Lot Numbers: 27468501, 27175521, 26730773, 26638897, 26438043, 25029926, 25598344; REF 89-6501.02, Lot Number: 27964281; REF 89-6609.04, Lot Numbers: 27222560, 26366457, 26315721, 26096952, 25876287, 25396232, 25201327; REF 89-6643.01, Lot Numbers: 26344346, 26437876, 26147991, 25876279, 25022652, 25594554; REF 89-6717.02, Lot Numbers: 24643625, 24643617; REF 89-7900.01, Lot Numbers: 27981460, 27981494, 28016813, 28039