Z-2748-2011

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

Name: Z-2748-2011 smith&nephew NO-STING SKIN-PREP No-Sting Protective Wipes Effective protection between tape and skin Reduces...
Creator: Smith & Nephew Inc.
Published: 2011-04-04
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2011-04-04 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc. began a recall of 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... on 2011-04-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2748-2011
Status: Terminated
Initiated: 2011-04-04
Posted: 2011-07-06
Terminated: 2011-07-18
Recalling firm: Smith & Nephew, Inc.
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 ----- 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***. ----- 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***. ----- 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***. ----- 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***. ----- 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***. ----- 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***. ----- Product Label: 9 month shelf life REF 66800494***RENASYS-G Gauze Dressing Kit - Medium 10mm Flat Drain*** Shipping Label: 66800494 QTY 15***. ----- 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***. ----- 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***. ------ 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***. ------ Product Usage: No-Sting Skin-Prep is indicated as an effective barrier between skin and tape.
Product code: KMF Bandage, Liquid
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
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot # 9K150, 9K151, 9L169, 9L170, 0E230, 0E231, 0J290, 0J291, 0J292.

Product code KMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)