Events

LocatorWand Cover 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical MD, 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
    36466
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0066-2007
  • 사례 출판 날짜
    2006-10-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48696
  • 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
    Locator-Wand Cover - Product Code MMP
  • 원인
    Smiths medical became aware that product returned to them under recall # z-0800-06/ z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. the product was originally recalled because locator wand covers, which are supplied on the outside of port-a-cath and p.A.S. port sterile trays, may have an insufficient seal and product sterility could be compromised.
  • 조치
    An Urgent Product Safety & Recall Notification, dated 09/27/06, was sent to customers via facsimile and phone calls were made. The letter describes the issue and customers are given 3 options to include: use only the sterile tray and discard the wand cover, remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers, or return the entire device for a credit or replacement.

Device

LocatorWand Cover
  • 모델명 / 제조번호(시리얼번호)
    Lot number M42880
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, FL, MA, MD, OH, OK, TX
  • 제품 설명
    Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • 제조사 주소
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA