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-2323-2014
  • 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
    laparoscopy kit - Product Code FDE
  • 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 900-414, 26 lots: 112030868 112041328 112051656 112062284 112072802 112093940 112104108 112114600 113015696 113025963 113036361 113036800 113057485 113068047 113068170 113088863 113089072 113099574 131110261 131210813 140111100 140211669 140311938 140412466 140412887 140513363
  • 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
    LAPAROSCOPY CHOLE PACK - - || ( 1) STRIP STERI CLOSURE W' X 4" LIF || ( 1) TABLE COVER REINFORCED 50" X 90" LIF || ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF || (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF || ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F || (5) TOWELS ABSORBENT 15" X 20" LIF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (4) DRAPE UTILITY WIT APE LIF || ( 1) COVER CAMERA W/ELAST LIF || (2) GAUZE SPONGE 4" X 4" 12PL Y LIF || ( 1) NEEDLE ULTRA VERES 120mm LIF || (2) DRAPE SHEET 41 " X 58" SMS LIF || ( 1) SCALPEL WEIGHTED SAFETY #11 || ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF || ( 1) DRESSING TEGADERM 4" X 4 %" LIF || ( 1) TUBE SUCTION CONNECT X" X 12' LIF || ( 1) MAYO STAND COVER REINFORCED LIF || ( 1) SUTURE BAG FLORAL LIF || ( 1) Pk. STERI STRIP LAP SET LATEX || ( 1) CORD LAPAROSCOPY MONOPOLAR LIF || ( 1) MAYO TRAY SMALL LIF || ( 1) TIME OUT BEACON NON WOVEN ST. LIF || (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF || ( 1) BAG ZIP LOCK PLASTIC 6" X 10" || 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