Events

Device Recall GEOMED BIOPSY TRAY 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Deroyal Industries, Inc. Lafollette 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58675
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2229-2011
  • 사례 시작날짜
    2011-02-07
  • 사례 출판 날짜
    2011-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99876
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Tray, surgical - Product Code LRP
  • 원인
    Custom surgical kits contained either one or more of the following possible contaminated recalled products: triad lubricating jelly, alcohol prep pads, and alcohol swabs.
  • 조치
    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 recalls@deroyal.com. 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.

Device

Device Recall GEOMED BIOPSY TRAY
  • 모델명 / 제조번호(시리얼번호)
    REF 89-7617.01: Lot Number 23700991; REF 47-003: Lot Numbers: 19930881, 14034148, 15104953; REF 47-094.019: Lot Number 20508661, REF 47-276.13: Lot Numbers: 17602649, 19555209, 20376793, 21093681, 22419187, 22683210, 24979698; REF 47-324: Lot Numbers: 17889221, 18103956, 18198174, 18782311, 19462176, 19930911, 20508688, 20841051, 21885303, 22898544, 23264965, 23909381, 24461442, 24721435, 24826376, 24870174, 24926879, 25051242; REF 47-327: Lot Numbers: 17830692, 18507723, 20434261, 20504978, 20689600 20796333; REF 47-483: Lot Numbers: 14128591, 18477552, 18871373, 19042121, 19251900, 19990972, 20189171, 20795058, 21097260, 24023557, 24095500, 24174697, 24203283, 24248043, 24808987; REF 47-491.12: Lot Numbers: 17784008, 18987974, 21361438, 22373001, 22772933, 22947297; REF 47-600: Lot Numbers: 17094939, 17217214, 17243463, 17538026, 17738634, 18550713, 18982727, 19491612, 20576681, 20597545, 20779787, 20873001, 21667226, 22195671, 22830380, 23278187, 24059576, 24220391; REF 47-626: Lot Numbers: 17227623, 17295327, 18507766, 18521306, 19310383, 19930953, 20503570, 21092194, 21521083, 22373043, 23251232, 23904248; REF 47-670.05: Lot Numbers: 17022468, 17390957, 18563750, 18755903, 19668318, 19930961, 21474248, 21617051, 22142755, 24310871; REF 47-743.01: Lot Numbers: 17841990, 18452507, 19327100, 19703814, 20178308, 21924659, 22354192, 22900561, 24311516, 24663458, 24924136; REF 47-777.02: Lot Numbers: 17594853, 17832541, 18987982, 19010591, 19313040, 19584712, 21339177, 21821158, 22934681, 23705839, 23846199, 24809496; REF 50-3474.02: Lot Numbers: 18588210, 19507080; REF 89-3899.01: Lot Numbers: 17880972, 18177197, 18691938, 18710967, 18909781, 19021821, 19213727, 19323002, 19517270, 19879799, 20009395, 20207308, 20495637, 21055140, 21317453, 21827031, 21839201, 22057382, 22731285, 22849558, 23336324, 23531023, 23778991, 24005738, 24746747, 24822480; REF 89-6306.02: Lot Numbers: 17682829, 17781843, 17884746, 19328381, 19569264, 19845329, 19883659, 20013571, 20371095, 20894128, 21500557, 21687016, 21841853, 22059839, 22736449, 23621889, 23879134, 24009798, 24294533, 24521222; REF 89-7650.01: Lot Number 24631085; REF 47-746.04: Lot Numbers: 17283351, 17537736, 17669261, 17796391, 18493296, 18750635, 18958621, 18982583, 19407302, 19690523, 20547257, 20597916, 20662280, 20936851, 21149437, 21544832, 21666944, 21707355, 21775500, 23074715, 23683203; REF 47-501: Lot Numbers: 18507758, 18521293, 18624479, 19555225, REF 47-004: Lot Numbers: 22898536, 17138831, 18755831, 20697511, 21116791; REF 47-751: Lot Numbers: 18429569, 19668529
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Kits and Trays containing alcohol swabstick/prep pad: || GEO-MED BIOPSY TRAY, V A MED CTR MARTINSBURG, REF 89-7617.01 || Rx Only, STERILE EO, Distributed by Geo-Med, LLC, 478 Altamonte Drive, Ste. 108, PMB 235, Altamonte Springs, FL 37201; DeRoyal (R) ST TPN/CVC DRG KIT W/VAD, REF 47-003, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) TPN/CVC Dressing Change Kit, REF 47-094.019, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TPN/CVC DRG CHG KIT, REF 47-276.13, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST CEN LINE KIT, REF 47-324, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST PED TRAY, REF 47-327, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST MAYO CLINIC PICC KIT, REF 47-483, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST PICC DRG CHG KIT, REF 47-491.12, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST IHC DRG CHG KIT, REF 47-600, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, Made in the Dominican Republic; DeRoyal (R) PRESBYT PIC KIT-NICU, REF 47-626.10, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST NEONATAL DRG CHG KIT, REF 47-670.05, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW PREP TRAY, UNIV OF ROCHESTER, REF 47-743.01, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; || DeRoyal (R) St. Central Line Kit, REF 47-777.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; || DeRoyal (R) ARTERIAL LINE HYPER TRAY-25C, UNIV VIRGINIA CHARLOTTESVILLE, REF 50-3474.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BONE MARROW BIOPSY, UNIVERSITY OF WASHINGTON, REF 89-3899.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) BIOPSY TRAY, PARKWAY RADIOLOGY, REF 89-6306.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ARTERIAL LINE TRAY, ERLANGER MEDICAL CENTER, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST DRESSING CHANGE KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Made in the Dominican Republic; DeRoyal (R) ST DIALYSIS KIT, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) ST TRN/CVC DRG KIT W/TRANS, Rx Only, STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; DeRoyal (R) CVC Dressing Change Kit, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA
  • Manufacturer
    Deroyal Industries, Inc. Lafollette

Manufacturer

Deroyal Industries, Inc. Lafollette
  • 제조사 주소
    Deroyal Industries, Inc. Lafollette, 1501 East Central Ave, La Follette TN 37766-2892
  • 제조사 모회사 (2017)
    Deroyal Industries Inc.
  • Source
    USFDA