Events

Recall of Adhesive Remover Wipe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58525
  • Event Risk Class
    Class 2
  • Event Number
    Z-2750-2011
  • Event Initiated Date
    2011-04-04
  • Event Date Posted
    2011-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99520
  • Notes / Alerts
    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.
  • Extra notes in the data
    Solvent, adhesive tape - Product Code KOX
  • Reason
    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.
  • Action
    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
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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.
  • Manufacturer Address
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA