Events

Recall of Protective Wipes (aqueous formulation)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58525
  • Event Risk Class
    Class 2
  • Event Number
    Z-2748-2011
  • Event Initiated Date
    2011-04-04
  • Event Date Posted
    2011-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99515
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bandage, liquid - Product Code KMF
  • Reason
    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
    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.

Device

Protective Wipes (aqueous formulation)
  • Model / Serial
    Lot #  9K150,  9K151,  9L169,  9L170,  0E230,  0E231,  0J290,  0J291,  0J292.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.
  • Manufacturer Address
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA