Events

Device Recall Various custom surgical kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Custom Assemblies 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
    77962
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3059-2017
  • 사례 시작날짜
    2017-06-15
  • 사례 출판 날짜
    2017-08-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158352
  • 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
    General surgery tray - Product Code LRO
  • 원인
    The firm manufactured and distributed custom surgical kits which contained bd safetyglide" 22ga 1¿ inch needles. bd subsequently recalled these needles because, " loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
  • 조치
    BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected consignees. Consignees were instructed to examine their inventory and quarantine any affected product. Consignees with questions should call 201-847-4267. For questions regarding this recall call 919-202-8462.

Device

Device Recall Various custom surgical kits
  • 모델명 / 제조번호(시리얼번호)
    (a) Lot Numbers: 42754-1603, 42798-1603, 43030-1604  (b) Lot Numbers: 42696-1602, 43200-1604, 433322-1605  (c) Lot Numbers: 43056-1604,  (d) Lot Numbers: 42836-1603, 43182-1604  (e) Lot Numbers: 42794-1603  (f) Lot Numbers: 42912-1603 (g) Lot Numbers: 43416-1606 (h) Lot Numbers: 43414-1606
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
  • 제품 설명
    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: || (a) CMS-4153-R2 MPM Biopsy TRAY || (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray || (c) CMS-4108 Multipurpose Safety Tray || (d) CMS-3141-R6 Custom Ultrasound Tray || (e) CMS-2891-R1 Custom Safety Biopsy Tray || (f) CMS-5798-R1 Custom Safety Biopsy Tray || (g) CMS-2357R2 Custom Biopsy Tray || (h) CMS-2540-R4 Custom Biopsy Tray
  • Manufacturer
    Custom Assemblies Inc

Manufacturer

Custom Assemblies Inc
  • 제조사 주소
    Custom Assemblies Inc, 330 E. Main Street, Pine Level NC 27568
  • 제조사 모회사 (2017)
    Custom Assemblies Inc.
  • Source
    USFDA