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-2397-2014
  • 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 900-1496, 22 lots: 112041078 112051677 112062422 112114953 113015550 113025817 113026047 113036320 113036750 113057690 113067952 113088734 113099274 113109735 131110178 131210749 140111077 140211644 140311921 140412602 140513092 140513391
  • 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
    D & C LAPAROSCOPY PACK - || (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT || (1) MAYO STAND COVER REINFORCED UF || (4) DRAPE UTILITY UF || (1) TRAY MAYO SMALL LIF || (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL || (1) SUTURE BAG FLORAL LIF || (1) TUBE SUCTION CONNECT X" X 12' LIF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (2) LEGGINGS WITH 7" CUFF 30" X 42" LIF || (1) UTILITY BOWL 32oz. UF || (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX || (2) DRESSING NON ADH TELFA 4 X 3 ST. UF || (1) JELLY LUBRICATING FIVE GRAM || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) *Pk. STERI STRIP LAP SET LATEX || (1) COVER CAMERA W/ELAST UF || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF || (4) TOWELS ABSORBENT 15" X 20" UF || (1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF || (2) LIGHT SHIELD || (1) DRESSING TEGADERM 4" X 4 %" LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP || (1) SCALPEL WEIGHTED SAFETY #11 || (1) BAG ZIP LOCK || (1) Pk. STRIP STERI CLOSURE W' X 4" LIF || (1) TIME OUT BEACON NON WOVEN ST. UF || (1) BANDAGE GAUZE STRETCH 4" || (1) NEEDLE ULTRA VERES 120MM UF || (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF || (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F || 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