Events

Device Recall NIPRO, GLUCOPRO INSULIN SYRINGES 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nipro Medical 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
    54358
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1103-2010
  • 사례 시작날짜
    2010-01-13
  • 사례 출판 날짜
    2010-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88327
  • 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
    Disposable Insulin Syringe - Product Code FMF
  • 원인
    Nipro medical corporation, miami fl is initiating a nationwide recall of all glucopro insulin syringes (this does not include the glucopro syringe specific for use with the amigo insulin pump). these syringes may have needles that detach from the syringe. if the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in.
  • 조치
    Each consignee will receive a Recall Notification Letter and response form by either fax or e-mail. Product should be returned to point of sale. Product not distributed should be collected and returned to Nipro Medical Warehouse in Memphis TN and Carolina Puerto Rico. Any questions or concerns can be addressed to the company at 787.769.2522.

Device

Device Recall NIPRO, GLUCOPRO INSULIN SYRINGES
  • 모델명 / 제조번호(시리얼번호)
    A08022,  A08013,  A08017,  C08022,  C08013,  C08017,  B08013,  B08017.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (including Puerto Rico) Foreign Distribution: Canada, Barbados, Honduras, Jamaica, Panama, Trinidad and Tobago, and Costa Rica.
  • 제품 설명
    NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. || Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). || JD+01U3008-5C 1cc 30G x 5/16"; || JD+01U3013-5C 1cc 30G x 1/2"; || JD+01U3108-5C 1cc 31G x 5/16"; || JD+03U3008-5C .3CC 30 g X 5/16"; || JD+03U3013-5C .3CC 30 g X 1/2"; || JD+03U3108-5C .3cc 31G x 516"; || JD+05U3008-5C .5cc 30G x 5/16"; || JD+05U3013-5C .5cc 30G x 1/2"; || JD+05U3108-5C .5cc 31G x 5/16".
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • 제조사 주소
    Nipro Medical Corporation, 3150 Nw 107th Ave, Miami FL 33172
  • 제조사 모회사 (2017)
    Nipro Corporation
  • Source
    USFDA