Events

Device Recall Mick TP Prostate Seeding Needle 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mick Radio Nuclear Instr 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
    32046
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0857-05
  • 사례 시작날짜
    2005-03-30
  • 사례 출판 날짜
    2005-06-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39007
  • 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
    Needle, Isotope, Gold, Titanium, Platinum - Product Code IWF
  • 원인
    Some of the mick tp prostate seeding needles do not fit properly into the mick 200-tpv applicator. firm received one complaint during use of the mick 200 tpv applicator.
  • 조치
    Recall Notices (dated 3/30/05) were sent to the consignees by First Class Mail on 3/30/05. Follow-up phone calls to the consignees were initiated on 4/22/05. Recall was expanded for 7 additional lots, and recall notices (dated 8/09/05) were sent to the direct consignees (medical facilities).

Device

Device Recall Mick TP Prostate Seeding Needle
  • 모델명 / 제조번호(시리얼번호)
    Lots: M121504-07 (Exp. 12/15/09), M012605-01 (Exp. 1/26/10), M012805-01 (Exp. 1/28/10); --- 8/09/05 RECALL EXPANSION (7 Lots): M110204-01 (Exp. 11/02/09), M110204-04 (Exp. 11/02/09), M110504-02 (Exp. 11/05/09), M120804-01 (Exp. 12/08/09), M120904-01 (Exp. 12/09/09), M121004-03 (Exp. 12/10/09), M121404-01 (Exp. 12/14/09)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Medical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom.
  • 제품 설명
    Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.
  • Manufacturer
    Mick Radio Nuclear Instr Inc

Manufacturer

Mick Radio Nuclear Instr Inc
  • 제조사 주소
    Mick Radio Nuclear Instr Inc, 521 Homestead Avenue, Mount Vernon NY 10550-4619
  • Source
    USFDA