Navigation Links
Urgent: OTC DRUG Nationwide Recall--Important information for patients about IV PREP Antiseptic Wipes
Date:3/5/2011

ST. PETERSBURG, Fla., March 5, 2011 /PRNewswire/ -- 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.

Contraindications:  None.

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.

Forward-Looking Statements

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.


'/>"/>
SOURCE Smith & Nephew
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Nationwide Survey Reports that Mothers View Cleaning Homes and Toys as Essential to Preventing Colds & Flu
2. 10 Million Square Feet of Turf Set to be Treated in 2008 in Response to MRSA Outbreaks Nationwide
3. Hydrox Inc., Cardinal Health Issue Nationwide Recall of Alcohol-Free Mouthwash For Hospitals
4. Nationwide Progress Poll Reveals Increased Efforts by Hospitals to Control MRSA Infection
5. Nationwide Survey Shows Infertility Patients Prefer ENDOMETRIN(R) Compared With Other Progesterone Supplements
6. Diabetes Experts Issue New Recommendations for Inpatient Glycemic Control - Call for Systemic Changes in Hospitals Nationwide
7. mPay Gateway Teams With Allscripts to Provide Point-of-Care Patient Payment Tools to Physician Practices Nationwide
8. Video: EmFinders EmSeeQ(TM) Now Available to Locate Wandering Individuals in Emergency Situations Nationwide
9. Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Now Available in Pharmacies Nationwide
10. McNeil Consumer Healthcare Announces a Voluntary Nationwide Recall of All Lots of TYLENOL(R) Arthritis Pain 100 Count With EZ-OPEN CAP
11. Merz Pharmaceuticals Introduces New Mederma(R) Stretch Marks Therapy Now Available in Drugstores Nationwide
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Market - Forecast to 2022" report to their offering. ... method for the patients with kidney failure, it replaces the ... from the patient,s blood and thus the treatment helps to ... chloride in balance. Increasing number of ESRD ...
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
Breaking Medicine Technology:
(Date:6/27/2016)... , ... June 27, 2016 , ... "FCPX editors can ... inside of Final Cut Pro X," said Christina Austin - CEO of Pixel Film ... Final Cut Pro X users can now reveal the media of their ...
(Date:6/27/2016)... , ... June 27, 2016 , ... ... edge technology to revolutionize the emergency ambulance transport experience for the millions of ... of how Uber has disrupted the taxi industry through the use of technology. ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, ... Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility ... home to some of the world’s leading providers of cereal and other breakfast foods. ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... 2016 , ... Austin residents seeking Mohs surgery services, can now turn to ... Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to ... fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of ...
Breaking Medicine News(10 mins):