Device Recall CYSTOSCOPY/IRRIGATION SET 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira Inc. 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
    68129
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1625-2014
  • 사례 시작날짜
    2014-03-25
  • 사례 출판 날짜
    2014-05-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-12-06
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    System, irrigation, urological - Product Code LJH
  • 원인
    The tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: list no. 04693-01, latex free extension set; list no. 06543-01, nonvented y-set for transurethral resection; list no. 06544-01 cystoscopy / irrigation set; list no. 06599-01, large bore y-irrigation set (latex-free); and, list no. 15239-01, 4-lea.
  • 조치
    Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated March 25, 2014 to all affected customers. The letter included instructions for the direct accounts to: 1) check their inventories and quarantine any of the affected products; 2) complete and return the attached reply form to the fax number or e-mail address on the form; 3) inform potential users of these products of this recall; 4) return the affected products to Stericycle using the labels provided with the letter (additional labels or reply forms can be obtained by calling Stericycle at 877-377-5128, Monday - Friday, 8:00 AM - 5:00 PM EST); and, 5) if the products were further distributed, notify those customers and request that they contact Stericycle at 877-377-5128 (Monday - Friday, 8:00 AM - 5:00 PM EST). An updated URGENT MEDICAL DEVICE RECALL letter dated March 28, 2014 was sent to all affected customers. The letter contained instructions similar to those found in the March 25, 2014 letter.

Device

  • 모델명 / 제조번호(시리얼번호)
    List No. 6544-04-01 (6544-01); Lot Numbers: 13107NS, 13108NS, 13171NS, 13172NS, 15141NS, 15142NS, 15143NS, 16113NS, 16114NS, 16115NS, 16116NS, 16174NS, 16175NS, 16176NS, 17134NS, 18112NS, 19130NS, 19131NS, 19132NS, 20119NS, 20120NS, 20121NS, 21130NS, 21131NS, 21207NS, 22144NS, 22145NS, 23107NS, 23108NS, 23109NS, 23110NS, 23111NS, 23112NS, 24194NS, 24204NS, 25133NS, 25254NS, 27110NS, 27111NS, 27155NS, 28192NS, 28271NS, 28272NS, 29097NS, 29170NS, 29171NS, 30197NS, 30198NS, 30199NS, 30200NS, 31044NS, 31045NS, 32231NS, 32232NS, 32391NS, 33328NS, 34170NS, 34170NS, 34171NS, 34287NS, 35115NS, 35116NS, 35250NS, 36160NS
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US: Nationwide in the states of (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates
  • 제품 설명
    LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira || Product Usage: || For Constant or Intermittent Bladder Irrigation
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
  • Source
    USFDA