Device Recall PDS Plus Antibacterial monofilament syntheticabsorbable sutures 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon, 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
    79541
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1339-2018
  • 사례 시작날짜
    2018-01-10
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • 원인
    Three (3) lots were distributed with the incorrect expiry date on the label. the lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
  • 조치
    On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required: 1. Examine inventory and quarantine all affected product 2. Communicate this recall notice to all affected personnel at facility, or other affected facilities. 3. Complete the business reply form attached to the recall letter. 4. Keep the recall notice posted visibly at facility and maintain a copy with your records 5. Return unused product to recalling firm by April 13, 2018. For further assistance contact 1-855-215-5039.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution US Nationwide, Canada, India, and Colombia.
  • 제품 설명
    PDS Plus Antibacterial (Polydioxanone) Suture || Size 1 PDS PLUS Violet 27 || Single Armed OS-4 Needle
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ethicon, Inc., Us Highway 22 West, Somerville NJ 08876
  • 제조사 모회사 (2017)
  • Source
    USFDA