smith&nephew NO-STING SKIN-PREP No-Sting Protective Wipes Effective protection between tape and skin Reduces risk of tap

FDA device recall Z-2748-2011 · posted 2011-07-06 · Terminated

Recall details

Recalling firm

Smith & Nephew Inc.

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

Action taken

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

Status

Terminated

Product code

KMF

Quantity affected

108490 cartons (471800 wipes); 192,945(kits containing wipes)

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, H

Date initiated

2011-04-04

Date posted

2011-07-06

Date terminated

2011-07-18

Location

Saint Petersburg, FL