Events

Busse Suction Instrument with Tubing 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Busse Hospital Disposables 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
    28815
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0845-04
  • 사례 시작날짜
    2004-04-13
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-02-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32569
  • 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
    Unit, Suction Operatory - Product Code EBR
  • 원인
    Firm received complaints of "melting" at tubing connection. the connecting part of the yankauer becomes soft after extended direct contact with the pvc tubing. this results in a slower rate of suction.
  • 조치
    Urgent Product Recall Letters and Response Forms were sent to the consignees via Registered Mail on 4/13/04.

Device

Busse Suction Instrument with Tubing
  • 모델명 / 제조번호(시리얼번호)
    Barcode: *+H8003051W*. Lots: 0020491, 0020510, 0020607, 0021386, 0120147, 0120211, 0120265, 0120377, 0120585, 0120904, 0121194, 0121312, 0220006, 0220200, 0220302,  0220550, 0220779, 0220925, 0221006, 0320104, 0320179,  0320230, 0320408, 0320556, 0320680, 0320973.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributors and end users (hospitals, fire departments/EMS) located nationwide, in Puerto Rico, St. Thomas, Canada, Dominican Republic, Panama, Uganda, Dubai, and Abu Dhabi, United Arab Emirates.
  • 제품 설명
    Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
  • Manufacturer
    Busse Hospital Disposables

Manufacturer

Busse Hospital Disposables
  • 제조사 주소
    Busse Hospital Disposables, 75 Arkay Drive, Hauppauge NY 11788-3707
  • Source
    USFDA