Events

Device Recall RENASYSF Foam Dressing Kit with Soft Port 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew 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
    67477
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1158-2014
  • 사례 시작날짜
    2014-01-09
  • 사례 출판 날짜
    2014-03-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125527
  • 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
    negative pressure wound therapy Powered suction pump - Product Code OMP
  • 원인
    Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate soft port sealing at the wound site or improper positioning of the soft port orifice over the wound contact dressing drape. inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wo.
  • 조치
    A product bulletin titled "Soft Port Enhancements" dated March 14, 2013, was released for external distribution describing the changes to the Soft Port products, e.g. increasing the Soft Port orifices size and adding a second slit to the release paper covering the port adhesive, and stating the purpose of the modifications to the device. These product bulletin was provided to sales representatives for distribution to customers requesting information regarding the design enhancement made to the Soft Port product range. The bulletin was not distributed to all the customers. To ensure that the product modification and its purpose was appropriately communicated to consignees of affected product a Medical Device Correction Notice, dated 01/22/2014, retrospectively advising customers of the modification to the Soft Port products has been prepared and was sent to consignees of the affected products on the same date.

Device

Device Recall RENASYSF Foam Dressing Kit with Soft Port
  • 모델명 / 제조번호(시리얼번호)
    ALL LOT #'s: 2013011828 and lower- Small, 2013010125 and lower- Medium, and 2013011692 and lower - Large
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, KY, LA, MA, MS, MT, NC, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV, HI and the countries Dubai, Curacao, Argentina, Australia, Chile, Germany, France, England, Hong Kong, Kuwait, Lebanon, Libya, Sri Lanka, Malaysia, New Zealand, Manila, Saudi Arabia, South Africa, Singapore, Turkey, Taipei and Vietnam.
  • 제품 설명
    Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.
  • 제조사 주소
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA