Events

Device Recall Anchor Tissue Retrieval System TRS100SB 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Anchor Products Company, 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
    57432
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1590-2011
  • 사례 시작날짜
    2010-12-09
  • 사례 출판 날짜
    2011-03-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96202
  • 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
    laparoscope, general & plastic surgery - Product Code GCJ
  • 원인
    The metal component within the unit can break and cause a malfunction. use of the device may represent a potential health hazard if the metal component is not removed after breakage.
  • 조치
    The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.

Device

Device Recall Anchor Tissue Retrieval System TRS100SB
  • 모델명 / 제조번호(시리얼번호)
    Code TRS100SB, lots P05N, P07N, P11N, P13N, P19N, P20N, P23N, P25N, P29N, P30N, P31N, P34N, P37N, P41N, P42N, P43N, P44N, P46N, P47N, P48N, P49N, P51N, P52N, P53N, P55N, P56N, P57N, P58N, P60N, P61N, P66N, P68N, P69N, P71N, P75N, P78N, P85N, P90N, P94N, P94N, P96N, P98N, P99N, Q02N, Q04N, Q05N, Q06N, Q09N, Q11N, Q12N, Q13N, Q14N, Q17N, Q20N, Q23N, Q24N, Q30N, Q31N, Q36N, Q38N, Q41N, Q49N, Q50N and Q65N
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.
  • 제품 설명
    Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB || The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
  • Manufacturer
    Anchor Products Company, Inc.

Manufacturer

Anchor Products Company, Inc.
  • 제조사 주소
    Anchor Products Company, Inc., 52 W Official Rd, Addison IL 60101-4519
  • 제조사 모회사 (2017)
    Anchor Products Company
  • Source
    USFDA