Events

Device Recall S.A.L.T. Airway Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Microtek Medical Inc 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
    57743
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1885-2011
  • 사례 시작날짜
    2011-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97299
  • 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
    Product contains triad lubricating jelly which was recalled.
  • 조치
    The firm, Microtek Medical, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and place any S.A.L.T. Airway Device (79-580) in quarantine; if they have distributed any of the product, they should identify their customers and notify them at once of this recall; complete and return the enclosed URGENT: MEDICAL DEVICE RECALL-RETURN RESPONSE form via fax to: (662)244-3011 or email: tom.bonner@ecolab.com, and return any unused product inventory to Microtek Medical. The firm will provide the customers with a replacement product as soon as product becomes available. If you have any questions in regards to this recall, please feel free to contact the V.P.-Regulator Affairs at 1-888-844-0988 or email: Tom.bonner@ecolab.com.

Device

Device Recall S.A.L.T. Airway Device
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: C10259 and D103334
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: AZ, CA, CT, FL, IN, MS, NC, NH, PA, TX and WI.
  • 제품 설명
    MDI(R), S.A.L.T. Airway Device, Supraglottic Airway Laryngopharyngeal Tube, Intended for use with 6.5mm -9.00mm ET tubes, Including SALT(TM) airway, ET tube clamp, Latex-free securing strap, Tongue blade, Lubricating jelly, NON STERILE, REF 79-580, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, Manufactured in the Dominican Republic of U.S. Materials || Supraglottic Airway Laryngopharyngeal Tube which can be used to facilitate blind, endotracheal intubation.
  • Manufacturer
    Microtek Medical Inc

Manufacturer

Microtek Medical Inc
  • 제조사 주소
    Microtek Medical Inc, 602 N Lehmberg Rd, Columbus MS 39702-4406
  • 제조사 모회사 (2017)
    Ecolab Inc
  • Source
    USFDA