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-2309-2014
  • 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
    Obstetrical kit - Product Code OKV
  • 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 900-168, 34 lots: 110061523 110092042 110092166 110092388 110112612 110123053 111010060 111020331 111041058 111051332 111061506 111071775 111082059 111102842 111113023 111123371 112072440 112083401 112114642 112125025 113026049 113036454 113036752 113057838 113078270 113088750 113089158 113109744 131110336 140111166 140211649 140211925 140513102 140513461
  • 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
    Customed LABOR & DELIVERY PACK - Includes: || (1) TABLE COVER 44" x 90" || (2) LEGGINS WITH/7" CUFF 30" x 42" || (5) ABSORBENT TOWELS 15" x 20" LIF || (1) BABY BLANKET PRINTED LIF || (2) PAD OBSTETRICAL XLGE LIF || (1) EAR ULCER SYRINGE 2oz. LIF || (1) BABY BLANKET POLY ABS. IMP. LIF || (1) Pr. SURGICAL GLOVE # 7Y2 || (1) UNDER BUTTOCK DRAPE WITH POUCH || (1) BEANNIES BABY LIF || (1) FEEDING TUBE 8 Fr. 15" LONG LIF || (1) ABDOMINAL DRAPE WITH TAPE L/F || (1) DRAPE SHEET 41 " X 58" SMS || (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV || (1) VAGINAL SPONGE XRD || (1) UMBILICAL CORD CLAMP LIF || (2) CLOTH HUCK TOWELS BLUE || (1 0) GAUZE SPONGE 4" X 4"16 PLY XRD LIF || (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2 || (1) MUCUSTRAP 20cc 1 OFr. || (1) BOWL PLASTIC 80oz WITH LID || (1) WRAPPER 24" X 24" LIF || 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