Events

Recall of Protective Wipes

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-2749-2011
  • 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=99516
  • 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, skin protectant - Product Code NEC
  • 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
  • Model / Serial
    420400 SKINPREP Lot #  0D169,  0D182,  0D190,  0D150,  0D200,  0F164,  0F165,  0F182,  0F183,  0F184,  0G137,  0G165,  0G184,  0G185,  0G215,  0G282,  OJ293,  0H116,  0H117,  0H123,  0H266,  0H267,  0J124,  0J125,  0J126,  0J85,  0K118,  0K119,  0K120,  0K254,  0K255,  0K271,  0K272,  0L164,  0L165,  0L205,  0L206,  0L225,  0L226,  0L227,  0L241,  0L242,  0M199,  0M200,  06K120,  1A246,  1A247,  1A248,  1A256,  1A257,  1A258.   59420425 SKINPREP CE Lot #:  0G117,  0G225,  0J146,  0J147,  0K78,  0M198.   420471 SKINPREP BULK Lot #: 0D149,  0F184,  0J127,  9M165,  0M109,  1A277.    5132 PERI-PREP Lot #: OC232, 0G243.
  • 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
    BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling || ***smith&nephew; ***#420400***SKIN-PREP Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping Helps tape, film and appliance adhesion Reduces friction Pediatrician tested***1 wipe***For external use only. Do not use with electrocautery procedures. Sting will be experienced if contacts cut or open wound. INGREDIENTS: Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. || ------------------- || Brand: SKIN-PREP Protective Wipes Bulk Case:***smith&nephew;***SKIN-PREP Wipes BULK*** REF 420471 QTY 1000 Wipes ***. || ------------------- || Brand: SKIN-PREP CE Protective Wipes - Pouch Label: ***smith&nephew;*** #59420425***SKIN-PREP***Box Label: ***smith&nephew;***#59420425 SKIN-PREP 50***Carton Label: smith&nephew; Wipes For International Export ***Quantity 20 Cartons of 50 REF #59420425***. || ------------------ || Brand: PERI-PREP CE Protective Wipes - Pouch Label and Box Label: || ***Peri-Prep Peristomal Protective Dressing Wipe Product Code 840001 FOR ***SALTS HEALTHCARE***WARNINGS: Use only as directed. For external use only. do not apply to open wounds or mucus membrane. Avoid contact with eyes. Vapor may be harmful - use with adequate ventilation. Do no use with electrocautery procedures. FLAMMABLE: Do not use near heat, sparks or open flame. Keep out of reach of children. Seek medical advice before use on neonates. FIRST AID TREATMENT: If swallowed, give victim milk or water and induce vomiting. Call physician or poison control center immediately. If inhaled, remove to fresh air. If not breathing give artifical respiration, call physician. In case of contact with eyes, flush with water for 15 minutes including under eyelids. INGREDIENTS; Isopropyl Alcohol, Butyl Ester of PVM/MA Copolymer, Acetyl Tributyl Citrate. || Brand: PERI-PREP CE - Case Label: || ***smith&nephew; Wipes Re-order #84001 ***PERI-PREP CE FLAMMABLE*** Quantity 20 Cartons of 50 REF #5132***. || --------------- || The following brand name products are manufactured using the same formulation . || 1) SKIN-PREP Protective Wipes 50/Box Formulation F-06, Product Code 420400. || 2) SKIN-PREP Protective Wipes Bulk Case 1000/Case Formulation F-06, Product Code 420471. [1000 individual wipes in a poly bag placed into a shipping carton.] || 3) SKIN-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code 59420425. || 4) PERI-PREP CE Protective Wipes 50/Box Formulation F-06, Product Code || 5132. || Product Usage: Alcohol based liquid film-forming skin preparations that, upon application to intact skin, form a protective film to help reduce friction during removal of tapes and films. Skin-Prep can also be used to prepare skin attachment sites for drainage tubes, external catheters, surround ostomy sites and adhesive dressings.
  • 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