Events

Adhesive Remover Wipe 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
    58525
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2750-2011
  • 사례 시작날짜
    2011-04-04
  • 사례 출판 날짜
    2011-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99520
  • 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
    Solvent, adhesive tape - Product Code KOX
  • 원인
    Smith & nephew, inc., st. petersburg, fl is recalling multiple lot numbers of the following products: remove universal adhesive remover wipes, uni-solve adhesive remover wipes, skin-prep protective wipes, peri-prep protective wipes, and no-sting skin-prep protective wipes. these products were manufactured by h&p; industries dba the triad group who has initiated a recall of products manufactured i.
  • 조치
    Smith & Nephew Inc. sent an "URGENT DEVICE CORRECTION" letter dated April 8, 2011 to all customers who received the recalled products. The letter described the product, problem and the appropriate actions to be taken. Customers are instructed to immediately discontinue using the recalled products, examine their inventory, and follow the return or disposition instructions provided. The letter instructed customers to seek an alternative product for use. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271.

Device

Adhesive Remover Wipe
  • 모델명 / 제조번호(시리얼번호)
    UNISOLVE 402300 Lot #  0F195,  0F197,  0F198,  0F223,  0F224,  0F228,  0F229,  0F239,  0H185,  0H226,  0H228,  0H229,  0K207,  0K208,  0K209,  0K233,  0K234,  0M136,  0M137,  0M151,  0M238,  1A103,  1B129,  1B130,  1B131,  1B132.   REMOVE CE 59403125:  0E219,  0E226,  0F242,  0G116,  0H256,  0J233,  0J262,  0J263,  0M178,  0M179,  1A106,  1A181,  1A182,  1A192.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of: NC, PA, NM, OR, VA, TN, NY, OR, AL, IL, MN, TX, and Puerto Rico and the countries of: Australia, Canada, England, France, Germany, Hong Kong, Japan, Mexico, New Zealand, Singapore, South Africa, Taiwan, and United Kingdom
  • 제품 설명
    Brand: UNI-SOLVE Adhesive Remover Wipe  Pouch, 50 Count Box Label || ***smith&nephew;***#402300*** UNI-SOLVE Adhesive Remover Wipe Effectively removes tapes and adhesives Reduces irritation and risk of skin stripping Easy to use, no mess Gentle***1 wipe*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: C10-11 Isoparaffin, Isopropyl Alcohol, Dipropylene Glycol Methyl Ether, Aloe Extract, Fragrance. || Brand UNI-SOLVE Adhesive Remover Wipes - Carton Label: || smith&nephew; Adhesive Remover Wipes ***UNI-SOLVE***Quantity 20 Cartons of 50 Code #402300*** || -------------------- || Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: || ***smith&Nephew;***#59403125***REMOVE***US Patent no. 5336207***CE***. || Formulation F-57 S&N; Product Code 402300 UNI-SOLVE Adhesive Remover Wipes. || Formulation F-57 S&N; Product Code 59403125 REMOVE CE Adhesive Remover. || Product Usage: Reduce adhesive trauma to the skin by thoroughly dissolving dressing tape and appliance adhesives. || .
  • 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