Events

Device Recall Plum A Infusion Pump, Single Channel 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
    64261
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2728-2016
  • 사례 시작날짜
    2013-02-06
  • 사례 출판 날짜
    2016-09-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148267
  • 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
    The fluid shield diaphragm for the plum a+ infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
  • 조치
    Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field.

Device

Device Recall Plum A Infusion Pump, Single Channel
  • 모델명 / 제조번호(시리얼번호)
    List number 12348, Serial Numbers: 13740156, 13740256, 13740266, 13740351, 13740380, 13740451, 13740508, 13740612, 13740632, 13740731, 13740732, 13740733, 13740734, 13740735, 13740736, 13740737, 13740738, 13740739, 13740740, 13740741, 13740742, 13740743, 13740744, 13740745, 13740746, 13740747, 13740748, 13740749, 13740750, 13740751, 13740752, 13740753, 13740754, 13740755, 13740756, 13740757, 13740758, 13740759, 13740760, 13740761, 13740762, 13740763, 13740764, 13740765, 13740766, 13740767, 13740768, 13740769, 13740770, 13740771, 13740772, 13740773, 13740774, 13740775, 13740776, 13740777, 13740778, 13740779, 13740780, 13740781, 13740782, 13740783, 13740784, 13740785, 13740786, 13740787, 13740788, 13740789, 13740790, 13740791, 13740792, 13740793, 13740794, 13740795, 13740796, 13740797, 13740798, 13740799, 13740800, 13740801, 13740802, 13740803, 13740804, 13740805, 13740806, 13740807, 13740808, 13740809, 13740810, 13740811, 13740812, 13740813, 13740814, 13740815, 13740816, 13740818, 13740819, 13740820, 13740821, 13740822, 13740823, 13740824, 13740825, 13740826, 13740827, 13740828, 13740829, 13740830, 13740831, 13740832, 13740833, 13740834, 13740835, 13740836, 13740837, 13740838, 13740839, 13740840, 13740841, 13740842, 13740843, 13740844, 13740845, 13740846, 13740847, 13740848, 13740849, 13740850, 13740851, 13740852, 13740853, 13740854, 13740855, 13740856, 13740857, 13740858, 13740859, 13740860, 13740861, 13740862, 13740863, 13740864, 13740865, 13740866, 13740867, 13740868, 13740869, 13740870, 13740871, 13740872, 13740873, 13740874, 13740875, 13740876, 13740877, 13740878, 13740879, 13740880, 13740881, 13740882, 13740883, 13740884, 13740885, 13740886, 13740887, 13740888, 13740889, 13740890, 13740891, 13740892, 13740893, 13740894, 13740895, 13740896, 13740897, 13740898, 13740899, 13740900, 13740901, 13740902, 13740903, 13740904, 13740905, 13740906, 13740907, 13740908, 13740909, 13740910, 13740911, 13740912, 13740913, 13740914, 13740915, 13740916, 13740917, 13740918, 13740919, 13740920, 13740921, 13740922, 13740923, 13740924, 13740925, 13740926, 13740927, 13740928, 13740929, 13740930, 13740977, 13740980, 13740982, 13740986, 13740994, 13741025.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
  • 제품 설명
    Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
  • Manufacturer
    Hospira Inc.

Manufacturer

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