Events

Covidien 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Covidien LLC 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
    75302
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0365-2017
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150070
  • 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
    General surgery tray - Product Code LRO
  • 원인
    Added instructions for use: after application, inspect the light glove for barrier integrity.
  • 조치
    Medtronic issued a Correction Notice on September 29, 2016. Customers were notified via Federal Express and the letter informed customers of the addition of the following statement to the Instructions for Use (IFU): After application, inspect the Light Glove for barrier integrity. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 962-9888

Device

Covidien
  • 모델명 / 제조번호(시리얼번호)
    All lot codes in the following: Item Number Decription 56479 7335-SMC DELIVERY KIT 573208 7519-DHCG SURGI-START KIT 573210 7581-CSD SURGI-START KIT 573310 7417-SSC SURGI-START KIT 573326 7497-HLS MINI-PLUS KIT 573328 7437-NRF SURGI FOOTPACK ASCKIT 573343 7499-88 SURGICAL KIT 573346 7499-TLG SURGICAL KIT 573359 7499-HLW MINI-PLUS KIT 573368 7494-CAB2 SURGICAL KIT 573370 7411-SSI MINI PLUS KIT 573509 7696-GSL-VL SINGLE BASIN KIT 573529 7697-T4E SINGLE BASIN SURGI KI 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 573713 7553-SBT MINI-PLUS KIT 573732 7620-CWA SURGICAL ASC KIT 573741 7667-HMI SURGICAL ASC KIT 573776 7520-BHP SURGICAL ASC KITS 573777 7527-BHB SURGICAL ASC KITS 573798 7496-8KB MINI-PLUS KIT 573799 7516-UNIKB SET-UP KIT 573813 7590-GHF HAND AND FOOT PACK 773501 7692-WIW2 SURGI-START KIT 773701 7600-ESC SURGI-START KIT 31140208 3611 FLEXBL LITE GLOVE 1EA/PKG 31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG 31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG 31141479 K-1842-S STD. MINI-KIT STERILE 31141487 K-1560-S3 STD. MINI KIT STER. 31141495 K-1530-S3 STANDARD MINI-KIT 31141537 K-1940-S STD. MINI KIT STER. 31141552 K-1920-S STANDARD MINI-KIT 31141560 K-1200-S3 STD MINI-KIT 31141578 K-1840-S STD. MINI KIT STER. 31141586 K-1660-S STD. MINI-KIT STER. 31141602 K-1630-S STD. MINI KIT STER. 31141610 K-1615-S STD. MINI KIT STER. 31141628 K-1614-S STD MINI-KIT 31141651 K-1560-S STD. MINI KIT STERILE 31141669 K-1530-S STD. MINI KIT 31141677 K-1200-S STD. MINI KIT 31141784 K-1960-S STANDARD MINI-KIT 31141859 K-1615-S3 STD MINI-KIT 31141875 K-1940-S3 STD. MINI-KIT STER. 31144507 7519 BUNNY KIT - GENERAL BUNNY 31144879 7815 SURGI-START KIT STERILE 31144895 7614-T4 SURGI-START KIT 31144960 7693-T4 SURGI-START KIT 31144978 7766 SURGI-START KIT 31145025 7496-8 MINI-PLUS KIT - STERILE 31145215 7896 STANDARD SURGI-START KIT 31145231 7897 STD, SURGI-START KIT 31145249 7897-T8 SURGI-START KIT STER 31145298 7896-T8 STANDARD,SURGI START 31145363 7496-88 STANDARD,MINI-PLUS KIT 31145397 7497-8 STANDARD MINI PLUS KIT 31145413 7497-88 STANDARD,MINI-PLUS KIT 31145496 7696-T4 STANDARD SURGI-START 31145504 7708 STANDARD SURGI-START KIT 31145520 7614 SURGI-START KIT STERILE 31145546 7693 SURGI-START KIT STERILE 31145629 7696 STANDARD SURGI-START KIT 31145645 7608 SURGI START KIT STERILE 31149720 7496-NNB VAR. MINI PLUS KIT 31150470 7496-PUP VAR. MINI PLUS KIT 31152302 7896-NNB VAR. SURGI-START KIT 31153060 7697-T4 SURGI-START KIT 31153938 7756-KST VAR.SURGI-START KIT 31154266 7656-KST VAR. SURGI-START KIT 31175089 7497-8T6 STD MINI-KIT PLUS 31175105 7553-NAL VARIATION BUNNY KIT 31314720 7514-CCS VARIATION BUNNY KIT  31321097 7697 STD SURGI-START KIT  31324299 7830-HOH STD PLUS SURGI-START  31361234 7460-CNR2 MINI-PLUS KIT STD KT  31404851 BIRTHDAY KIT STANDARD PLUS  31451092 7600-DNV SURGI-START KIT STD  31451480 7493-SFW MINI-PLUS KIT STD  31453098 7682-MHP SURGI-START STD PLUS  31457131 7461-SMS MINI-PLUS KIT STD PLU  31460432 7596-SHH STD PLUS BUNNY KIT  50000148 K-1920-COE MINI-KT STAND-PLUS  50000510 7500-END STANDARD SURGICAL KIT  50000511 7516-UNI STANDARD SURGICAL KIT  50000512 7557-UNI UNIVERSAL SURGICAL KT  50000515 7667-BRT SURGI-START KIT STRD.  50000568 7605-SEC SURGI STANDARD PLUS K  50000599 7694-ADA SURGI-START KIT  50000947 7413-CAD MINI-PLUS KIT  50000980 7897-SME SURGI-START KIT  50001029 7417-PCP MINI-PLUS KIT  50001033 7520-FSF MINOR KIT  50001052 7427-CFS MINI-PLUS KIT  50001057 7484-HHS MINI-PLUS KIT  50007698 7698-T4 STANDARD SURGI-START K  50007699 7699-T4 STANDARD SURGI-STAR  50007898 7898-T8 STANDARD SURGI-START K  50007899 7899-T8 STANDARD SURGI-START K  50047403 7496-HCS MINI-PLUS KIT  50047405 7496-HES MINI-PLUS KIT  52000076E C-SECTION PACK  52000082E DELIVERY KIT  573375A MINI-PLUS KIT  573830D MINOR KIT  573831B MAJOR KIT
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
  • 제품 설명
    Covidien Devon Light Glove sub-assembly non-sterile || For Kit Packers || Product Usage: || A disposable, sterile, single-use cover for compatible surgical light handles
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • 제조사 주소
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA