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U.S. Department of Health and Human Services

Class 2 Device Recall Adhesive Remover Wipe

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  Class 2 Device Recall Adhesive Remover Wipe see related information
Date Initiated by Firm April 04, 2011
Date Posted July 06, 2011
Recall Status1 Terminated 3 on July 18, 2011
Recall Number Z-2751-2011
Recall Event ID 58525
Product Classification Solvent, adhesive tape - Product Code KOX
Product Brand REMOVE Universal Adhesive Remover Wipe - Pouch Label and 50 count box Label:

***smith&nephew***#403100*** REMOVE Universal Adhesive Remover Wipes Gently removes tapes and adhesives Reduces risk of irritation and skin stripping Contains Aloe***1 wipe and 50 wipes*** For external use only. Avoid eyes - Use with adequate ventilation. Keep out of reach of children. INGREDIENTS: Dipropylene Glycol Methyl Ether, C10-11 Isoparaffin, Aloe Extract, Benzyl Alcohol, Fragrance.
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Brand: Universal Adhesive Remover Wipes - Carton Label:

***smith& nephew Universal Adhesive Remover Wipes ***Quantity 20 Cartons of 50 Code #403100***.


Product Usage: Adhesive removers gently clean all types of adhesive residue from the skin, including hydrocolloid-based, acrylic-based and ruber-based adhesives.
Code Information Lot #  0E145,  0E146,  0E194,  0E210,  0E211,  0G138,  0H135,  0H248,  0J190,  0J232,  0L147,  0M176,  0M177,  1A117,  1B112,  1B128. 
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 2		 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 118,896 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.
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