Events

Device Recall HEPARIN LOCK FLUSH SOLUTION 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 App Pharmaceuticals 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
    57878
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1825-2012
  • 사례 시작날짜
    2010-05-20
  • 사례 출판 날짜
    2012-06-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109646
  • 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
    Heparin, vascular access flush - Product Code NZW
  • 원인
    Cgmp deviations: incomplete documentation associated with test results.
  • 조치
    APP sent an URGENT DRUG RECALL LETTER and Response Form dated May 20, 2010, to all affected consignees. The consignees contacted were at the retail/ medical facilities/hospital IeveIs, including intermediate wholesale IeveIs. Direct distributor consignees were instructed to notify their customers immediately of this recall action, and direct them to discontinue distributing or dispensing the affected lots, plus return the affected products and lots to APP Pharmaceuticals, LLC in Bensenville, IL. Direct consignees with affected lots on hand were instructed to immediately discontinue distributing or dispensing the affected products and return them to APP Pharmaceuticals, LLC in Bensenville, IL 60106. Questions regarding the information on how to return product can be made to the firm's Quality Assurance Department at 1-866-716-2459. For questions regarding this recall call 847-969-2700.

Device

Device Recall HEPARIN LOCK FLUSH SOLUTION
  • 모델명 / 제조번호(시리얼번호)
    Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution and Puerto Rico
  • 제품 설명
    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only || To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
  • Manufacturer
    App Pharmaceuticals Llc

Manufacturer

App Pharmaceuticals Llc
  • 제조사 주소
    App Pharmaceuticals Llc, 1501 E Woodfield Rd, Suite 300 East, Schaumburg IL 60173-6052
  • 제조사 모회사 (2017)
    Fresenius SE & Co. KGaA
  • Source
    USFDA