—#99530

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. ------------------- 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.

FDA product code: KOX — Solvent, Adhesive Tape
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot # 0E145, 0E146, 0E194, 0E210, 0E211, 0G138, 0H135, 0H248, 0J190, 0J232, 0L147, 0M176, 0M177, 1A117, 1B112, 1B128.

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc.
Address: 970 Lake Carillon Dr, Ste 110, Saint Petersburg, Florida 33716-1130

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2011-04-04
Posted by FDA: 2011-07-06
Terminated: 2011-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99530. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.