Events

PTFE Coated 3 cm Flexible Tip Guidewire 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gyrus Acmi, Incorporated 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
    58650
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2383-2011
  • 사례 시작날짜
    2011-04-15
  • 사례 출판 날짜
    2011-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99779
  • 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
    Accessories, catheter, g-u - Product Code KNY
  • 원인
    Gyrus acmi, inc. wants to bring a recall issue to their customers attention concerning one lot of their 25bx-ptfe coated 3 cm flexible tip guidewire. as a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. in such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected,.
  • 조치
    The firm, Olympus ACMI, sent an "Urgent: Medical Device Recall" letter dated April 15, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Inspect their stock to confirm if any of the affected lot of products remains in their possession 2)Immediately cease any further use of the affected product, remove, quarantine and return it. 3) Call their Gyrus ACMI customer service representative at 1-888-542-7266 to obtain a Returned Goods Authorization 4) Return the product to: Attn: PTFE Guidewire Recall RGA#_________Gyrus ACMI LP, 6845 Wedgwood Court, Maple Grove, MN 55311 5) Complete and return the RECALL REPLY FORM via fax, even if they are returning no product, to: Regulator Affairs (508) 804-2624. The letter states that the customer will receive repeat mailings until they have faxed in the form. Additionally, If they have further distributed the product they are requested to identify and notify their customers at once. If you have any questions, please do not hesitate to contact customer service at 1-888-524-7266.

Device

PTFE Coated 3 cm Flexible Tip Guidewire
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 252410KC
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: CA, GA, HI, IN, KY, MT, NY, NC, PA, TX, UT, and WA.
  • 제품 설명
    Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA || Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • 제조사 주소
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA