Stryker Neptune 1 and Neptune 2 Waste Management Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zeppessis Reprocessing, LLC 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
    66176
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2212-2013
  • 사례 시작날짜
    2013-08-16
  • 사례 출판 날짜
    2013-09-17
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-11-08
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • 원인
    Zeppessis' reprocessed single-use manifolds (filters) for the stryker neptune 1 and neptune 2 waste management systems are recalled due to lacking 510k and and without a validated cleaning protocol for reprocessing the used manifolds.
  • 조치
    Zeppessis Reprocessing, LLC sent an Urgent Medical Device Recall letter dated September 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to stop using the Zeppessis reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems immediately and instructed to destroy the products in a proper manner. Customers should fill out the Customer Response form and fax or email it back to Zeppessis. For any questions about this recall, please call Zeppessis Reprocessing, LLC at 208-559-7064.

Device

  • 모델명 / 제조번호(시리얼번호)
    -Single-port manifold for the Stryker Neptune 1 (part # 700-015-000); -Four-port manifold for the Stryker Neptune 1 (part # 700-020-000);  -Single-port manifold for the Stryker Neptune 2 (part # 702-025-000);  -Four-port manifold for the Stryker Neptune 2 (part # 702-020-000).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of California, Idaho, Oregon, and Washington.
  • 제품 설명
    Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: || The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zeppessis Reprocessing, LLC, 121 E 38th St Ste 101, Garden City ID 83714-6495
  • Source
    USFDA