Class 2 Device Recall Protective Wipes

• Date Initiated by Firm: April 04, 2011
• Date Posted: July 06, 2011
• Recall Status: Terminated on July 18, 2011
• Recall Number: Z-2749-2011
• Recall Event ID: 58525
• Product Classification: Bandage, liquid, skin protectant - Product Code NEC
• Product: 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.
• Code Information: 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.
• 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: 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: 691,225 Boxes of 50 count
• 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.