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-2331-2014
  • 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
    Ring, laparotomy - 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 900-548, 60 lots: 109010181 109030603 109051042 109061206 109071558 109081861 109092069 109102334 109112579 109122695 110010096 110020395 110030677 110040948 110051248 110051360 110061461 110071847 110082073 110092262 110092399 110112663 110123108 111010139 111020289 111030691 111040905 111051209 111061555 111071826 111082102 111092553 111102766 111123268 112010186 112020489 112030845 112041337 112051995 112062490 112072805 112083434 112093640 112104099 112114678 113015454 113036442 113047025 113047205 113057493 113057747 113068175 113088875 113099441 113109856 131110266 131210828 140111238 140211731 140211940
  • 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
    PERY GYN PACK - || (1) TABLE COVER REINFORCED 44" X 78" UF || (2) TOWEL ABSORBENT 15" X 20" LIF || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED || (1) DRAPE UNDERBUTTOCK WITH POUCH || (1) UTILITY BOWL 16oz. || (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF || (1) ROBNEL CATHETER 18FR. || (1) DRAPE SHEET 41 " X 58" SMS || (2) LEGGINS WITH 7" CUFF 30" X 42" || (1) DRAPE UTILITY WITH TAPE UF || 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