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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
OTC DRUG Nationwide Recall--Important Information for Patients About IV PREP Antiseptic Wipes
Ogilvy Public Relations Worldwide
8:00 AM EST to 6:00 PM EST
FOR IMMEDIATE RELEASE - March 5, 2011 – Today, Smith & Nephew’s Advanced Wound Management division (LSE: SN; NYSE: SNN) announced a U.S. voluntary nationwide recall of selected lots of IV PREP Antiseptic Wipes (product number 59421200) manufactured for Smith & Nephew by The Triad Group.
This Smith & Nephew recall follows an earlier nationwide recall initiated by The Triad Group for alcohol prep products, pads, wipes and swabs due to concerns about potential microbial contamination with Bacillus cereus. Use of contaminated alcohol prep pads, wipes and swabs could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.
Smith & Nephew has halted all shipments of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. All customers and patients are advised to discontinue use of IV PREP Antiseptic Wipes immediately, as their use could result in localized or systemic infection. All customers should dispose of or return IV PREP Antiseptic Wipes to Smith & Nephew.
Smith & Nephew is advising all distributors and kit packers who utilize IV PREP Antiseptic Wipes as a part of their kit components to discontinue use of IV PREP Antiseptic Wipes immediately, and issue a sub-recall to their customers.
The specific lot numbers involved in the recall are: 9K141, 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259; 0K139, 0K140, 0K141; 0K193; 0M180; 0M216; 1A212, 1A213. IV PREP Antiseptic Wipes represent a small part of Smith & Nephew’s overall advanced wound management business.
As a precautionary measure, and out of concern for patient safety, Smith & Nephew contracted an independent laboratory to test all lots of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. The results showed there is no data to suggest that Smith & Nephew’s IV PREP Antiseptic Wipes have been compromised. To date, there have been no reported adverse events related to this voluntary recall.
Smith & Nephew is committed to providing customers with high quality, reliable product and has issued this voluntarily recall as a prudent, cautionary and conservative measure to assure patient safety and product performance. Smith & Nephew is working closely with the U.S. Food and Drug Administration (FDA) on this recall.
Further information on this Triad recall can be found on the FDA website at http://www.fda.gov/Safety/Recalls/ucm239219.htm. If you have additional questions regarding Smith & Nephew IV PREP Antiseptic Wipes, please contact the Smith & Nephew Customer Care at 1-800-876-1261 8:00 AM EST to 6:00 PM EST.
Important Information About IV PREP Antiseptic Wipes
Indications: For preparation of the skin prior to injection or venipuncture.
Warnings: Flammable, keep away from fire or flame. Do not use with electrocautery procedures. For external use only. Do not use in or near the eyes. Discontinue use if irritation or redness develop. If condition persists for more than 72 hours, consult a physician.
Precautions: For external use only; stop use and consult a doctor if the condition persists or gets worse. In case of deep or puncture wound, animal bits, or serious burns, consult a doctor. Discontinue use if irritation or redness develops. Do not use in the eyes.
Directions for use: Clean the area. Start at venipuncture site and apply in a circular fashion using friction. Allow to thoroughly air dry. Repeat with new wipe as necessary to cover sufficient area.
Active Ingredient: Isopropyl Alcohol 70% v/v
Inactive Ingredients: Acetyl tributyl citrate, butyl ester of PVM/MA copolymer, triclosan, water
About Smith & Nephew
Smith & Nephew is a global medical technology business with global leadership positions in Orthopaedics; including Reconstruction, Trauma and Clinical Therapies; Endoscopy; including Sports Medicine; and Advanced Wound Management. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.
Smith & Nephew is dedicated to helping improve people's lives. The Company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust. The Company has distribution channels, purchasing agents and buying entities in over 90 countries worldwide. Annual sales in 2010 were nearly $4.0 billion.
This press release contains certain "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995. In particular, statements regarding expected revenue growth and trading margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation, claims and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors.
All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.