Class 2 Device Recall Adhesive Remover Wipe

• Date Initiated by Firm: April 04, 2011
• Date Posted: July 06, 2011
• Recall Status: Terminated on July 18, 2011
• Recall Number: Z-2750-2011
• Recall Event ID: 58525
• Product Classification: Solvent, adhesive tape - Product Code KOX
• Product: 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. .
• Code Information: 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.
• Recalling Firm/ Manufacturer: Smith & Nephew Inc.; 970 Lake Carillon Dr; Ste 110; Saint Petersburg FL 33716-1130
• For Additional Information Contact: Terry McMahon; 727-392-1261
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Material/Component Contamination
• 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.
• Quantity in Commerce: 299726 Boxes of 50 count
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.