Device Recall Hospira, Inc. 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
    73799
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1833-2016
  • 사례 시작날짜
    2016-03-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-03-06
  • 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
    Pump, infusion - Product Code FRN
  • 원인
    Firm's investigation determined that the proximal occlusion alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
  • 조치
    Hospira Inc, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on March 31, 2016, to the direct consignees of record via traceable mailing which included a data capture log containing a list of devices located with each customer. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Please take the following actions related to Urgent Medical Device Correction letter notification: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. 3. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-877-479-8088 (M-F, 8am-5pm ET) to receive a reply form. Hospira will contact you to make arrangements for your impacted Plum 360 I Plum A+ devices to be re-calibrated to correct this issue. :

Device

  • 모델명 / 제조번호(시리얼번호)
    PLum A+ devices with the following list numbers: 12391-04-25, 12391-22-05, 12391-23-05, 12391-23-15, 12391-36-07, 12391-54-05, 12391-88-01, 12391-88-02, 12391-88-03, 12391-88-04, 12391-88-05, 20792-04-25, 20792-13-09, 20792-57-15, 20792-65-01, 20792-65-02 and 20792-88-69.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
  • 제품 설명
    The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. || Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming || feature.
  • Manufacturer

Manufacturer

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