Devices

Device Recall DeRoyal

  • Model / Serial
    DeRoyal C-Section Tracecart, REF 53-1746.02, Lot 12781158, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal CABG Tracepak, REF 90-2838.11, Lot 12830124, exp 2010-01, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal CABG Tracecart, REF 53-1865.03, Lot 12585413, exp 2008-08, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, Lot 12388751, exp 2009-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Neuro Tracecart, REF 53-1763.02, Lot 12680189, exp 2008-11, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Heart Tracecart, REF 53-1897.02, Lot 12729915, exp 2008-11, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracecart, REF 53-1862.03, Lot 12924403, exp 2010-05, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracepak, REF 90-2774.10, Lot 12493236, exp 2011-09, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Total Knee Tracecart, REF 53-1838.02, Lot 12585296, exp 2009-03, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, Lot 12570676, exp 2008-1105, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Heart Tracecart, REF 53-1725.13, Lot 12617657, exp 2008-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal C-Section Tracecart, REF 53-1837.03, Lot 11829924, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal C-Section Tracecart, REF 53-1781.04, Lot 12866047, exp 2008-10, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, Lot 12585405, exp 2009-03, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal Neuro Tracecart, REF 53-1815.06, Lot 12671151, exp 2008-01, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal AAA Tracecart, REF 53-1765.08, Lot 12862695 exp 2009-04, non-sterile, Rx only, DeRoyal, Powell, TN 37849  DeRoyal LAP Chole Tracecart, REF 53-1767.08, Lot 12671101, exp 2009-02, non-sterile, Rx only, DeRoyal, Powell, TN 37849
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Assorted non- sterile Tracecarts (with sterile component(s)); || DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracepak, REF 90-2838.11, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracecart, REF 53-1865.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Neuro Tracecart, REF 53-1763.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Tracecart, REF 53-1897.02, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracecart, REF 53-1862.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracepak, REF 90-2774.10, non-sterile, Rx only, DeRoyal, Powell, TN 37849; || DeRoyal Total Knee Tracecart, REF 53-1838.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Heart Tracecart, REF 53-1725.13, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Tracecart, REF 53-1837.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal C-Section Tracecart, REF 53-1781.04, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Neuro Tracecart, REF 53-1815.06, non-sterile, Rx only, DeRoyal, Powell, TN 37849; || DeRoyal AAA Tracecart, REF 53-1765.08, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal LAP Chole Tracecart, REF 53-1767.08, non-sterile, Rx only, DeRoyal, Powell, TN 37849
  • Manufacturer
    DeRoyal Lafollette
  • 1 Event

Manufacturer

DeRoyal Lafollette
  • Manufacturer Address
    DeRoyal Lafollette, 1501 East Central Ave, La Follette TN 37766
  • Source
    USFDA

17 devices with a similar name

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Device Recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution
  • Model / Serial
    REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Number 38276230; REF 89-7744.03, Lot Number 38229177;  REF 89-8194.02, Lot Number 38245020; REF 89-8439.01, Lot Number 38317548; REF 50-12160.17, Lot Number 38247391; REF 50-12602.09, Lot Number 38345266; REF 89-8381.01, Lot Number 38085071
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    SC, FL, OH, NJ, OK, MN, AR
  • Product Description
    DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: || TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; || KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; || TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; || PACEMAKER PACK, REF 89-8381.01;
  • Manufacturer
    DeRoyal Industries Inc
Device Recall DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Su...
  • Model / Serial
    REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    SC, FL, OH, NJ, OK, MN, AR
  • Product Description
    DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: || TOTAL JOINT PACK A&B;, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
  • Manufacturer
    DeRoyal Industries Inc
Device Recall DeRoyal Heart Tracecart
  • Model / Serial
    Lot Numbers: 27453624, 28013145, 28103757, 28117631, 28158774, 28215628, 28230174, 28252349, 28299104, 28317940, 28326230, 28405309, 28455138, 28486735, 28506265, 28568132, 28609969, 28631875, 28736343, 28793541, 28854180, 28908555 28961727, 29015839, 29083612, 29169512, 29214272, 29271744, 29339294, 29412771, 29522363, 29722357, 29754033, 29799485, 29850754, 30021523, 30092305, 30092604, 30134253, 30179216, 30728465, 30819738, 30957330, 31010691, 31015441, 31103782, 31296166, 31402993, 31469522, 31469709, 31576221, 31601554, 31671907, 32333862, 32335500, 32355746,  32550841, 32618796, 32689527, 32728688, 32764718, 32817091, 32834780, 32869000, 32933711, 32980699, 33011814, 33064334, 33087341, 33087350, 33197866, 33682175, 33736364, 33737623, 33783267, 34405461, 34699585, 34762863, 34768309, 34913043, 34939286, 34963841, 35170632, 35270238, 35270529, 35327337, 35544446, 35554708, 35580025, 35598516, 35710820, 35798577, 35828254, 35828449, 35870920, 35898261, 35952677, 36024274, 36081851, 36142094, 36142174, 36200101, 36273801, 36283541, 36309333 36341317, 36530441, 36605837, 36679545, 36953532, 37017210, 37079672,  37079787, 37083356, 37155305, 37189791, 37268916, 37331858, 37395771, 37396029, 37513643, 37654374, 38032551, 38088191, 38180246, 38235278, 38392951, 38457153, 38525030, 38551001, 38623300, 38625866, 38747370, 38788673, 38832507, 38832603, 38997758, 39013351, 39054022, 39076627, 39148951, 39579507, 39661447, 39706174, 39762352, 39812284, 39868780, 40017667, 40080121, 40149328, 40152447, 40264393, 40321968, 40322021, 40342363, 40380888, 40453186, 40453338, 40541549, 40607430, 40890010, 41161601, 41257048, 41263018, 41356935, 41411287, 41467416, 41544848,  41561980, 41601056, 41665404, 41740013, 41755485, 41755506, 42077436, 42077461, 42200721, 42332644, 42332661, 42406164, 42523723, 42523782, 42550246, 43479550, 43493941, 43531688, 43710715
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MS & LA
  • Product Description
    DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
  • Manufacturer
    DeRoyal Industries Inc
Device Recall DeRoyal SRHS Heart Tracecart
  • Model / Serial
    Lot Numbers: 27273826, 27324507, 27388691, 27453704, 27567701, 27760202, 27784829, 27883843, 27883851, 27915382, 27970710, 28013209, 28103933, 28117702, 28158889, 28158897, 28373571, 28506329, 28550670, 28678471, 28736415, 28793591, 28854235, 28908619, 28929145, 29015901, 29083680, 29169619, 29206205, 29271816, 29468459, 29522443, 29577604, 29631367, 29694350, 29754130, 29799557, 29850826, 29914025, 29914130, 29963231, 30021654, 30092364, 30092612, 30134245, 30143441, 30253965, 30312507, 30385597, 30487930, 30538274, 30608228, 30608236, 30618098, 30728570, 30776441,  30819771, 30906532, 30957381, 30990041, 31074854, 31155540, 31202772, 31338426, 31469590, 31469717, 31576230, 31671966, 31726138, 31776514, 31776549, 31780847, 31835027, 31886529, 31938886, 31939011, 31990297, 32050811, 32128560, 32133377, 32247761, 32247796, 32302978, 32315875, 32355800, 32421037, 32484206, 32544336, 32550891, 32605910, 32689586, 32764742, 32817154, 32869069, 32933761, 33011857, 33087405, 33217089, 33293188, 33357866, 33425822, 33482579, 33482595, 33539361, 33609787, 33682221, 33736436, 33807644, 33807759, 33876287, 34373462, 34450051,  34518799, 34574037, 34624356, 4699631, 34762927, 34826581, 34856368, 34913078, 34963833, 35033777, 35097560, 35170675, 35230658, 35270297, 35327370, 35400670, 35470555, 35523231, 35544500, 35598559, 35636885, 35638881, 35737011, 35774701, 35798614, 35850620, 35862954, 35877929, 36081869, 36107299, 36142123, 36200119, 36273810, 36282581, 36283559, 36341325, 36399631, 36465555, 36465627, 36548211, 36746488, 36823826, 36888726, 37017295, 37079744, 37155364, 37215937, 37269038, 37269142, 37297899, 37462031, 37513707, 37808046, 37869551, 37931204, 37976189,  38032593, 38088239, 38144000, 38180553, 38235294, 38236166, 38270188, 38270807, 38329400, 38392994, 38393399, 38457217, 38457250, 38573891, 38676461, 38688584, 38688648, 38734991, 38823441, 38898602, 39013335, 39063738, 39076660, 39201803, 39260598, 39303623, 39303631, 39353436, 39413822, 39502403, 39515394, 39559549, 39661519, 39706238, 39762395, 39812313, 39877694, 40272115, 40453207, 40522604, 40754595, 40754608, 40887005, 40888462, 41039809, 41080140, 41080166, 41161581, 41213150, 41279829, 41322330, 41356978, 41411210, 41467459, 41470068, 41544872,  41544901, 41601099, 41669982, 41713883, 41762247, 41830537, 41891081, 41980754, 42026874, 42078789, 42175386, 42240731, 42324142, 42345980, 42346077, 42367054, 42367062, 42368698, 42383628, 42467477, 42561121, 42561156, 42642790, 42679146, 43045591, 43091889, 43127731, 43166001, 43217189, 43454011, 43487584, 43501391, 43542580, 43588166, 43641406, 43742899, 43789030, 43824510, 43875309, 43916895, 43953506, 44039767
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MS & LA
  • Product Description
    SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
  • Manufacturer
    DeRoyal Industries Inc
Device Recall DeRoyal Sterile Custom kits
  • Model / Serial
    (a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to states of: CA and MO.
  • Product Description
    DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: || (a) Shoulder Arthroscopy Pack 89-8686.01 || (b) Shoulder Arthroscopy Pack 89-8686.02 || (c) Knee Arthro Pack 89-8687.01 || (d) Knee Arthro Pack 89-8687.02 || Product Usage: general surgical
  • Manufacturer
    DeRoyal Industries Inc
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