Terminated

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 Gentle1 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-SOLVEQuantity 20 Cartons of 50 Code #402300* -------------------- Brand: REMOVE CE Adhesive Remover Wipe - Pouch Label and 50 Count Box Label: smith&Nephew#59403125REMOVEUS Patent no. 5336207CE. 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. .

FDA Recall Z-2750-2011 · Posted 2011-07-06

Recalling FirmSmith & Nephew Inc.

Recall StatusTerminated

Product CodeKOX

Date Initiated2011-04-04

Date Terminated2011-07-18

Product Quantity299726 Boxes of 50 count

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

Firm 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.

Root Cause

Material/Component Contamination

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.