Events

Device Recall King Systems LTD Oropharyngeal Airway Kit 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
    57970
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1717-2011
  • 사례 시작날짜
    2011-01-14
  • 사례 출판 날짜
    2011-03-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97894
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • 원인
    King systems has been notified by triad group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use of this product may result in "patient infection". because this particular sterile lubricating jelly is packaged in the king lt-d kit and king lts-d kit, king systems is sending a notice of the reca.
  • 조치
    The firm, King Systems, sent an "URGENT PRODUCT RECALL" letter dated January 14, 2011 to its customers. King Systems sent a follow-up "URGENT PRODUCT RECALL" letter dated March 3, 2011 which "SUPERSEDES" the January 14, 2011 recall letter with attached instructions to its customers. The letters described the product, problem and actions to be taken by the customers. The customers were instructed to notify all their purchasers of this recall; immediately cease sales and use of the affected products; identify all inventory on hand or returned to them by their customers; REMOVE Triad Group lubricant from King LT-D and LTS-D kits according to King instructions; quarantine the Triad lubricant, re-seal the LT-D and LTS-D kits and destroy Triad lubricant or return to Triad according to King instructions, and complete, sign and return Recall Acknowledgement Form via fax to: 317-776-6827 or email to: triadluberecall@kingsystems.com. King Systems will provide replacement lubricant packs to all customers. Customers with questions regarding product return, replacement, hospital notification or concerning the information requested above, please contact Customer Service at 1-800-642-5464. If you have any regulatory questions about the recall, please contact Director of Quality Assurance and Regulatory Affairs at 1-800-642-5464.

Device

Device Recall King Systems LTD Oropharyngeal Airway Kit
  • 모델명 / 제조번호(시리얼번호)
    Product Code KLTD214, Lots: IHGB3, IHH94, IHLZ2, IHPZ2, IHRT5, IHTA4, IHWT5, IHZ51, II1B8, II536, II710, IIAQ4, II971, IICI7, IIJ75, IINU2, IIQJ4, IIVT4, IIWX7, IJ6A9, IJ9W0, IJE36, IJJW2, IISI9, IJLM6, IJNP8, IJQC6, IJTE2, IJWD7, IJVT9, IJX63, IJYS1, IJZ37, II2B9, IK3H9, IK4W6, IK789, IK8W7, IKEU4, IKH46, IKLC1, IKQN7, IKSE4, IIQJ3, II535, IHDV7, IKCX7, IKB55, IKU58, IKY62, IKVH9, IL1U8, IL6N5, IL8Y0, ILGE7, ILT63, ILV49, ILWG1, ILY48, IM126, IM1T5, IM954, IMAT2, IMBG6, IMGX8, IMIJ8, IMJJ6, IMNL7, IMR98, IMRI3, IMVN6, IMY92, IN1Q8, IN398, IN4W1, IN606, IN8U2, INCA4, INDW6, INFL1, INHS2, INIL3, INKH3, INLF1, INLT3, INMU3, INQE6, INS34, INW92, INY20, INZ16, IP4A9, IP4M6, IP6Y9, IP9B4, IPAL4, IPCY9, IPEQ9, IPIG6, IPJB3, IPKX3, IPN25, IPNS1, IPQC7, IPR19, IPST2, IPVK7, IPWC8, IPXT6, IPYB0, IQ263, IQ3V2, IQ4Z3, IQ8V2, IQ976, IQ9Q5, IQBR5, IQC58, IQDJ9, IQEY7, IQHC7, IQKI4, IQP22, IQUR8, IQZ79, IR1L8, IR9U8, IRAE9, IREA1, IRGT0, IRI32, IRM80, IRMS2, IRMS3, IRMS4, IRX32, IRXV2, IS217, IS218, IS584, IS879, ISC28, ISEU9, ISIX0, ISJT0, ISJT1, ISSG2, ISTP9, ISU99, ISUW5, ISWQ7, ISZ81, IT4K8, ITY7Y, IT7Y7, ITAE0, ITFH0, ITE20, ITFQ7, ITI17, ITMA1, ITPI8, ITSG9, ITW62, ITYX5, IU2U7, IU3Z3, IU7M5, IUAM0, IUC35, IUEI3, IUJF3, IULD3, IUS00, IUU61, IUY62 and IV147.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including: CA,CO, FL, ID, IN, KS, NC, NH, NY, OH, PA, PR, SC, TN, and TX; and Country of: Canada.
  • 제품 설명
    KING SYSTEMS, A Consort Medical Company, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 4, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Made in the U.S.A. || This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.
  • 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