Events

Spacelabs Healthcare HookUp kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Del Mar Reynolds Medical, Ltd. 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
    60205
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0262-2012
  • 사례 시작날짜
    2011-10-12
  • 사례 출판 날짜
    2011-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104739
  • 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
    Degreaser, skin, surgical - Product Code KOY
  • 원인
    The non-sterile alcohol prep pads (b339) are included in spacelabs healthcare hook-up kits may have the presence of a bacterium, bacillus cereus. these alcohol prep pads were manufactured and recalled by professional disposables international (pdi).
  • 조치
    SpaceLabs Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the affected product and dispose of them per their hospital or clinic protocol. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

Spacelabs Healthcare HookUp kits
  • 모델명 / 제조번호(시리얼번호)
    B339 is listed on the PDI Alcohol Prep Pads.  Hook-up kits that contain the affected alcohol prep pads are as follows:  Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (natiowide) and the countries of South Africa, Turkey, Bangladesh, Dominican Republic, Peru, Belgium, Ecuador, Romania, Austria, Honduras, Guatemala, Denmark, Republic of Korea, Argentina, Thailand, Italy, Austria, Chile, Bolivia, Mexico, Sweden, Netherlands, Switzerland, India, Serbia, Australia, Morocco, Turkey, ISpain, Czech Republic, Slovakia, Poland, China, Columbia, Portugal, Canada, Germany, United Kingdom, Singapore, France, Russian Federation, Bahrain, and Kuwait
  • 제품 설명
    PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . || Hook-up kits that contain the affected alcohol prep pads are as follows: || Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; || CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; || Aria, Kit Part number 23189-106, Kit, Aria Hookup; || Aria, Kit Part number 23189-110, Kit, Aria Hookup; || Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; || Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; || LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; || Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; || LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; || 483, Kit Part number 23189-117, Kit, Holter Hookup 483; || Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; || Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; || EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; || EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; || EVO, Kit Part number SK10456, Sample Kit, Disposables. || A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • 제조사 주소
    Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA