Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 SALTER LABS 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
    62272
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1898-2012
  • 사례 시작날짜
    2012-05-30
  • 사례 출판 날짜
    2012-06-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • 원인
    A complaint was received, and later verified, that product labeled as so-1296 with male luer lock connector actually contained product with a female luer lock connector.
  • 조치
    The firm, Salter Labs, called their customers to discuss the recall and followed up with a "PRODUCT RECALL" letter dated May 29, 2012. The letter was distributed to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any of the lots in their possession to Salter Labs; contact Salter Labs Customer Service at 1-800-235-4203 to arrange for return of the product, and complete and return the attached form/record via fax to: 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Device

  • 모델명 / 제조번호(시리얼번호)
    Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
  • 제품 설명
    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. || 7 ft, oxygen tube, 7 ft. CO2 tube || RX only.For Single Patient Use only. || Distributed by Tri-Anium || Assembled in Mexico. || Usage: Delivery of Anesthesia.
  • Manufacturer

Manufacturer

  • 제조사 주소
    SALTER LABS, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA