Device Recall Customed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Customed, 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
    68536
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2400-2014
  • 사례 시작날짜
    2014-05-20
  • 사례 출판 날짜
    2014-08-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-08-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    General surgery tray (kit) - Product Code LRO
  • 원인
    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
  • 조치
    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Device

  • 모델명 / 제조번호(시리얼번호)
    Product code 900-1521, 27 lots: 111102904 112041376 112041452 112062286 112104149 112114602 112124957 113015430 113015690 113025942 113026048 113036739 113046934 113047002 113047332 113057836 113078260 113088737 113088931 113089193 131110180 131110598 131210962 140211645 140211922 140412884 140513346
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • 제품 설명
    UROLOGY PACK- || (10) GAUZE SPONGE 4" X 4" 16PLY || (1) TUBE SUCTION CONNECT Y." X12' || (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK || (1) BASIN RING || (1) TUR Y SET, 2 LEAD, ST. || (1) BAG SUTURE FLORAL || (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV || (2) TOWEL CLAMP || (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS || (1) COVER TABLE REINF 50" X 90" || (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX || (3) TOWELS ABSORBENT 15" X 20" || (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV || (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (1) TIME OUT BEACON NON WOVEN ST. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • 제조사 모회사 (2017)
  • Source
    USFDA