Events

Excelsior Disposable Syringe W/Normal Saline 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Excelsior Medical Corp 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
    56685
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0035-2011
  • 사례 시작날짜
    2010-09-02
  • 사례 출판 날짜
    2010-10-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94277
  • 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
    saline, vascular access flush - Product Code NGT
  • 원인
    There is the potential for a dimensional issue in 6 ml syringe products, codes e0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, s5, to cause leakage and.Or loss of sterility.
  • 조치
    Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 2, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue using syringes from the listed lots and return the attached Customer Reply Form via fax (866) 688-3185 as confirmation that notification had been received and that proper arrangements can be made to have the product returned to the firm. The customers were also instructed to inform their customers, if they have resold products, of the recall and instruct them to return the form, and verify that they have returned all unused syringes from any of the listed lots . NOTE: The customers were informed that they may alternatively have the products destroyed and certified to Excelsior that they have done so. They must include a copy of the certificate of destruction with the attached Customer Reply Form via fax. - Excelsior issued a press release on October 14, 2010. The press release advised consumers of the recall and requested that use of the product be immediately discontinued and returned to the point of purchase. Should you have any questions regarding the recalled product, please contact Excelsior Medical Customer Service at (800) 487-4276 or if you prefer by fax (866) 688-3185. You may also contact us at recall10@excelsiormedical.com.

Device

Excelsior Disposable Syringe W/Normal Saline
  • 모델명 / 제조번호(시리얼번호)
    Product codesL E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000 and S5. Lot code/ Expiration date 26-011-DS 10/1/2010 28-010-DS 1/1/2011 32-010-DS 10/1/2010 79-017-9D 7/1/2011 84-038-9D 12/1/2011 86-020-9D 2/1/2012 83-034-9D 11/1/2011 88-120-9D 4/1/2012 32-024-DS 10/1/2010 23-029-DS 8/1/2010 27-034-DS 12/1/2010 29-011-DS 2/1/2011 79-018-9D 7/1/2011 79-021-9D 7/1/2011 81-070-9D 9/1/2011 88-076-9D 4/1/2012 32-011-DS 10/1/2010 21-029-DS 7/1/2010 30-023-DS 10/1/2010 67-023-9D 7/1/2010 67-034-9D 7/1/2010 68-050-9D 8/1/2010 68-052-9D 8/1/2010 68-053-9D 8/1/2010 68-054-9D 8/1/2010 69-041-9D 9/1/2010 70-019-9D 10/1/2010 70-021-9D 10/1/2010 70-025-9D 10/1/2010 70-030-9D 10/1/2010 70-042-9D 10/1/2010 71-005-9D 11/1/2010 71-008-9D 11/1/2010 72-007-9D 12/1/2010 72-022-9D 12/1/2010 72-023-9D 12/1/2010 72-024-9D 12/1/2010 73-010-9D 1/1/2011 73-014-9D 1/1/2011 73-017-9D 1/1/2011 73-019-9D 1/1/2011 73-024-9D 1/1/2011 73-027-9D 1/1/2011 74-036-9D 2/1/2011 74-039-9D 2/1/2011 74-046-9D 2/1/2011 74-053-9D 2/1/2011 74-054-9D 2/1/2011 74-056-9D 2/1/2011 74-059-9D 2/1/2011 75-001-9D 3/1/2011 75-004-9D 3/1/2011 75-017-9D 3/1/2011 75-051-9D 3/1/2011 75-052-9D 3/1/2011 75-056-9D 3/1/2011 75-057-9D 3/1/2011 76-003-9D 4/1/2011 76-006-9D 4/1/2011 76-010-9D 4/1/2011 76-031-9D 4/1/2011 77-063-9D 5/1/2011 77-067-9D 5/1/2011 83-032-9D 11/1/2011 83-033-9D 11/1/2011 83-040-9D 11/1/2011 83-047-9D 11/1/2011 83-048-9D 11/1/2011 84-039-9D 11/1/2011 84-040-9D 12/1/2011 86-021-9D 2/1/2012 88-121-9D 4/1/2012 88-133-9D 4/1/2012 89-118-9D 5/1/2012 89-136-9D 5/1/2012 67-001-9D 7/1/2010 67-004-9D 7/1/2010 67-021-9D 7/1/2010
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including Canada and Brazil.
  • 제품 설명
    Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) || General hospital use
  • Manufacturer
    Excelsior Medical Corp

Manufacturer

Excelsior Medical Corp
  • 제조사 주소
    Excelsior Medical Corp, 1933 Heck Ave, Neptune NJ 07753
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA