Events

Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synovis Surgical Inovation Div. of 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
    37671
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0961-2007
  • 사례 시작날짜
    2007-03-16
  • 사례 출판 날짜
    2007-06-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51279
  • 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
    Surgical Mesh - Product Code FTM
  • 원인
    Package integrity/sterility compromised-the foil pouch in the peri-strips dry with veritas collagen matrix circular staple line reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
  • 조치
    Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.

Device

Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV)
  • 모델명 / 제조번호(시리얼번호)
    5719288-345247, 5720137-358402, 5720206-359198, 5721249-375999, 5721733-391018, 5723148-421902, 5722090-397033, 5722420-406658, 5723509-433792, 5723703-439270, 5723810-441317, 5724696-467329, 5725034-478977, 5725483-487063, 5725792-495462, 5726121-498548, 5726493-506246, 5721249-540340, 5726841-516569. EXPANDED LOT/SERIAL #'s: 5726841-560767, 5726842-516570, 5727664-532483, 5727970-538817, 5727971-538818, 5728410-544892, 5728683-549953, 5729326-562208, 5729700-569547, 5729701-569548.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI
  • 제품 설명
    Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
  • Manufacturer
    Synovis Surgical Inovation Div. of

Manufacturer

Synovis Surgical Inovation Div. of
  • 제조사 주소
    Synovis Surgical Inovation Div. of, 2575 University Ave W, Saint Paul MN 55114-1073
  • Source
    USFDA