Device Recall Hudson RCI Humidifier Adaptor, 040 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical 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
    70280
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1100-2015
  • 사례 시작날짜
    2015-01-14
  • 사례 출판 날짜
    2015-02-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-12-04
  • 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
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • 원인
    The packages may contain foreign material (black particles).
  • 조치
    Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product Code: 003-40F, Lot numbers: 506147, 238137, 288137, 298137, 292147, 062147, 045147, 066147, 565137, 393137, 468137, 242137, 404137, 462147, 462137, 511137, 077147, 360137, 384137, 350137, 267137, 233147, 314137, 388137, 542137, 525137, 302137, 014147, 276147, 046147, 198147, 258147, 277147, 490147, 482147, 192147, 057147, 117147, 227147, 011147, 120147, 464137, 201147, 382137, 073147, 002147, 505147, 480147, 195147, 598137, 005147, 601137, 333137, 251147, 291137, 521137, 535137, 489147, 301137, 347137, 386137, 562137, 466137, 091147, 459147, 589137, 595137, 068147, 508137, 325137, 285137, 254147, 395137, 327137, 357137, 310137, 539137, 496137, 049147, 053147, 093147, 009147, 007147, 587137, 591137, 344137, 399137, 584137, 121147, 188147, 494147, 330137, 402137, 339137, 519137, 264137 & 260137.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
  • 제품 설명
    AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. || Product Usage: || The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • 제조사 모회사 (2017)
  • Source
    USFDA