March 8, 2011

FTNW: IV PREP Recall

http://www.fda.gov/Safety/Recalls/ucm239219.htm

http://www.pharmabiz.com/NewsDetails.aspx?aid=61752&sid=2

I don't see any instructions about what to do other than toss the stuff out. Smith didn't have any alternative other than wait. I was told to contact our supplier for a refund.
Smith & Nephew recalls selected lots of IV PREP Antiseptic Wipes from US markets

St. Petersburg, Florida
Tuesday, March 08, 2011, 14:00 Hrs [IST]

Smith & Nephew's Advanced Wound Management division announced a US 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 US Food and Drug Administration (FDA) on this recall.

For preparation of the skin prior to injection or venipuncture. It is 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.

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.

6 comments:

Anonymous said...

Triac Group alcohol pads were recalled but I did not even think about Smith and Nephew IV Preps, which we do use. I would think these should have been recalled immediately at the time Triad had problems with their alcohol wipes. Time has elapsed and these wipes have been used unwittingly. No problems so far but I am pissed.

BILL_42 said...

Does anyone know where exactly the lot number is printed on the box?I have been unable to locate it anywhere-thanks

Anonymous said...

It's stamped on the bottom of each individual packet, some also have it on the inside lip of the box.

Anonymous said...

Has anyone found replacements. Our pump supplies say it will be 4 to 6 weeks until replacements are sent out...and I only have 2 left from another box??

Kyla said...

I am using everyday alcohol wipes. Did any of you notice an increase in redness at infusion site after using the IV Prep? I have but figured it was just my skin being sensitive...

Anonymous said...

I am really pissed it is now May 9, 2011 and still no replacement received I have called at least 3 times and get the same stupid answer you should be getting them any day now and if you need more you should purchase them at your pharmacy...can I make a complaint any where. I think this is ridiculous that we should wait this long for a replacement when we have already paid for the product. I am totally pissed!!!