Events

Device Recall Stryker PainPump2 BlockAid 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 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
    50189
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0926-2009
  • 사례 시작날짜
    2008-11-12
  • 사례 출판 날짜
    2009-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76476
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    The pump may display an e-4 error message, which causes the pump to stop dispensing the pain medication.
  • 조치
    Consignees were notified via letter dated 11/12/08 and instructed to locate and destroy the affected lots. Customers were also instructed to complete and return the enclosed Business Reply form via fax (336-499-8603) to Stryker Instruments Regulatory Department. For questions regarding the recalled product, please contact Stryker Instruments at 1-800-800-4236, extension 3808 or extension 4056.

Device

Device Recall Stryker PainPump2 BlockAid
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 08219012, 08220012, 08221012, 08222012, 08225012, 08226012, 08229012, 08231022, 08233012, 08234012, 08235012, 08238022, 08239012, 08241012, 08242012, 08243012, 08246022, 08247012, 08249032, 08250012, 08252022, 08252032, 08253012, 08254012, 08256032, 08256042, 08257012 and 08259022.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA and country of Canada.
  • 제품 설명
    Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. Stryker, Kalamazoo, MI; REF 575-100, Product Number 0575-100-000. || The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management, the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous and epidural routs. It is also intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management, in which case routes of administration may be intraoperative, perineural or percutaneous.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Portage MI 49002-9704
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA