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U.S. Department of Health and Human Services

Class 2 Device Recall Protective Wipes (aqueous formulation)

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  Class 2 Device Recall Protective Wipes (aqueous formulation) 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-2748-2011
Recall Event ID 58525
Product Classification Bandage, liquid - Product Code KMF
Product smith&nephew NO-STING SKIN-PREP No-Sting Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping Improves tape, film and appliance adhesion No-sting, non-irritating Reduces friction:Packaged 50 wipes per box.
Formulation No. F-63, Product code 59420600
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Device Kits containing NO-STING SKIN-PREP Pouch
Package Label: 12 month shelf life
REF 66800882***RENASYS-G/P Gauze Dressing Kit with Port Small Kit***Rx only CE***.Case Label: REF 66800882 QTY 15***.
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Package Label: 12 month shelf life
REF 66800883***RENASYS-G/P Gauze Dressing Kit with Port Medium Kit*** Rx only CE***. Case Label: REF 66800883 QTY 15***.
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Product Label: 12 month shelf life
REF 66800884***RENASYS-G/P Gauze Dressing Kit with Port Large Kit*** Rx only CE***. Shipping Label: REF 66800884 QTY 15***.
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Product Label: 9 month shelf life
REF 66800491***RENASYS-G Gauze Dressing Kit - Small 10 Fr Round Drain*** CE***Rx only***. Case Label: REF 66800491 QTY 15***.
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Product Label: 9 month shelf life
REF 66800492***RENASYS-G Gauze Dressing Kit - Small 10mm Flat Drain*** ***Rx only CE ***. Case Label:REF 66800492 QTY 15***.
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Product Label: 9 month shelf life
REF 66800493***RENASYS-G Gauze Dressing Kit - Medium 15 Fr Channel Drain*** ***Rx only CE ***. Shipping Label: REF 66800493 QTY 15***.
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Product Label: 9 month shelf life
REF 66800494***RENASYS-G Gauze Dressing Kit - Medium 10mm Flat Drain*** Shipping Label: 66800494 QTY 15***.
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Product Label: 9 month shelf life
REF 66800495***RENASYS-G Gauze Dressing Kit - Large 19 Fr Round Drain*** **Rx only***. Shipping Label: REF 66800495 QTY 15***.
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Product Label: 9 months shelf life
REF 66800496***RENASYS-G Gauze Dressing Kit - Large 10mm Flat Drain*** ***Rx only CE ***. Shipping Label: REF 66800496 QTY 15***.
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Package Labeling: 9 months shelf life
***REF 66800212***HIGH OUTPUT / FISTULA KIT Irrigation/Aspiration Drain - 28 Fr WOODING-SCOTT Technique***Rx Only CE ***. Shipping Label: REF 66800212 QTY 10***.
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Product Usage: No-Sting Skin-Prep is indicated as an effective barrier between skin and tape.
Code Information Lot #  9K150,  9K151,  9L169,  9L170,  0E230,  0E231,  0J290,  0J291,  0J292.  
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 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, 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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