Events

Device Recall Face Tent with 15 mm Adapter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 King Systems Corp. 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
    57972
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1887-2011
  • 사례 시작날짜
    2011-01-24
  • 사례 출판 날짜
    2011-04-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97883
  • 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
    Oxygen Mask - Product Code BYG
  • 원인
    The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. the sticky substance could result in inconvenience or in some remote cases cause patient harm.
  • 조치
    The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter.

Device

Device Recall Face Tent with 15 mm Adapter
  • 모델명 / 제조번호(시리얼번호)
    IMKV8, IMNJ2, IMQX3, IMSR0, IMU97, IMXX0, IN1H1, IN3A2, IN6Z6, INAA6, INEE0, INF59, INGU4, INHT1, INJ16, INJE6, INK63, INL04, INLT4, INMV2, INPN6, INQF6, INRF2, INSP0, INRY6, INV51, INUU4, INVN4, INX39, INY27, IP0P6, IP332, IP208, IP4N1, IP5T2, IP7D7, IPAM0, IPBQ2, IPCZ7, IPE42, IPER6, IPGS5, IPIG9, IPKY4, IPLV3, IPML1, IPNS8, IPR26, IPU82, IPVM0, IPXC3, IPZ51, IQ024, IQ1E2, IQ271, IQ336, IQ3W0, IQ4Z9, IQ6Q5, IQAL8, IQCR8, IQDL1, IQIS8, IQLU4, IQMU0, IQQD4, IQSS6, IQWZ8, IR1G6, IR6J0, IR478, IRAF6, IRBP4, IRCG4, IRFT7, IRJS0, IRHK1, IRML5, IRPF5, IRU08, IRQF9, IRT66, IRSN2, IS092, IRXQ7, IS3H4, IS594, IS752, ISBS0, IS9N1, ISG89, ISHR7, ISL99, ISTV2, ISRV6, ISXQ0, IT186, IT3P1, ITAE7, IT727, ITAE8, ITBU2, ITFH4, ITI28, ITLC4, ITN42, ITPJ9, ITUQ8, ITXK1, IU4S4, IU3K4, ITZJ7, IU8B3, IUFH9, IUI17, IUKN7, IUN60, IUQL4, IUTA9, IUVY5, IUY74, IUZT5, IV1V5, IV432, IV6A3, IV887, IV7G0, IV9P8, IVCZ0, IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA.
  • 제품 설명
    Face Tent with 15 mm Adapter, REF MD126, Manufacturer: King Systems Nobleville, IN. || An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
  • Manufacturer
    King Systems Corp.

Manufacturer

King Systems Corp.
  • 제조사 주소
    King Systems Corp., 15011 Herriman Blvd, Noblesville IN 46060
  • 제조사 모회사 (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA