ClearanceBrief
Recall Z-2751-2011 ยท KOX Solvent, Adhesive Tape

Smith & Nephew Inc.

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: Dipropyl

DateJul 6, 2011 (initiated Apr 4, 2011)
StatusTerminated
ReasonSmith & 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 causeMaterial/Component Contamination
ActionSmith & 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 questi
Quantity118,896 boxes of 50 count
DistributionWorldwide 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.