Events

Device Recall HSG Procedure Tray 5Fr 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Device Technologies, 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
    57585
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0214-2012
  • 사례 시작날짜
    2010-12-22
  • 사례 출판 날짜
    2011-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96706
  • 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
    Catheter care tray (kit) - Product Code OHR
  • 원인
    Medical device technologies, inc. dba angiotech, is recalling hsg procedure trays and bone biopsy trays distributed between december 2007 and december 14, 2010 for package integrity.
  • 조치
    The firm, Angiotech, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 22, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product. If you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.

Device

Device Recall HSG Procedure Tray 5Fr
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 660005000 Lot Number(s): 81561NUN; 81561NUO; 81581NW4; 81961OM8; 82061OU8; 82121OY5; 82341PEQ; 82461PLA; 82521PQ0; 82811Q75; 82821Q7N; 82871QAN; 82901QDL; 83111QRI; 83251R2O; 83291R3V; 83391R9U; 90191S0X; 90261S5Q; 90261S5R; 90271S87; 90361SFQ; 90471SM9; 90611SYH; 90681T3K; 90751T6T; 91061TUC; 91201U5F; 91201U5G; 91211U6O; 91211U6P; 91411UKV; 91981VPX; 92031VTV; 92151W0I; 92251W8T; 92661WXJ; 92681X1E; 92721X4R; 92801X8L; 92861XCN; 92861XCX; 93001XLL; 93081XPK; 93351Y5B; 93351Y5C; 93421YAX; 93501YGQ; 00041YNO; 00391Z97; 00431ZD4; 00611ZPB; 009620AK; 010420GG; 012020QR; 013220Z4; 015221AO; 018121RH; 019321U6; 02102299; 021422A7; 022422HF; 023522N5; 0265234L; 02732396; 028523IF.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
  • 제품 설명
    Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (5Fr); 1 - Fixed Volume Syringe - 2cc; 1 - CSR Wrap (30"x30")***Catalog Number: 660005000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, customer_service@angio.com, www.angiotech.com. || HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.