If you have infants or toddlers or know someone who does, please read this!
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If you have infants or toddlers or know someone who does, please read this!
Parents blame toddler's death on tainted alcohol wipes
Millions of pads, swabs recalled because of same bacteria that killed 2-year-old boy
By JoNel Aleccia
Health writer
msnbc.com msnbc.com
updated 2/15/2011 8:21:03 AM ET
The parents of a 2-year-old Houston boy who died from a rare infection are suing makers of recalled alcohol prep products, claiming contaminated wipes and swabs transmitted bacteria that caused his fatal case of meningitis.
Sandra and Shanoop Kothari say their lively, dark-eyed toddler, Harrison, was recovering just fine from surgery to remove a benign cyst from near his brain and spinal cord last fall. But the day before he was set to be discharged after a week's stay, he developed a sudden and severe infection that worsened rapidly, causing multi-organ failure that led to Harrison’s death on Dec. 1, 2010.
Cultures showed he succumbed to acute bacterial meningitis caused by Bacillus cereus, bacteria typically found in rare food poisoning outbreaks, but not in hospital infections.
“They had no explanation as to how he contracted it,” said Sandra Kothari, 37, Harrison’s mother. “They know it’s rare in the hospital.”
Rare bacteria detected
For more than a month, the family grieved without knowing the cause of their loss. Then, on Jan. 5, a relative saw a notice posted online by the U.S. Food and Drug Administration. All lots of alcohol prep wipes, perhaps tens of millions of swabs and pads manufactured by the Triad Group, a Wisconsin medical product supplier, were being recalled.
The reason? Potential contamination with Bacillus cereus.
“These wipes were used in his care every single day, multiple times a day,” said Shanoop Kothari, Harrison’s father.
Officials at Children’s Memorial Hermann Hospital in Houston, where Harrison was treated, confirmed that the alcohol prep products they used were supplied by Triad, said the Kotharis’ lawyer Jim Purdue Jr. Samples of Triad products were taken from the room where Harrison stayed, he added. Shanoop Kothari said the recall offered terrible confirmation.
“We’re confident that that’s the cause,” said Kothari, 38, who works in the banking industry. “There was no other explanation that made any sort of sense. He contracted a very rare bacteria. These swatches were tainted with that bacteria.”
Lawyers filed a complaint Sunday in U.S. District Court in Houston. It charges the Triad Group of Hartland, Wis., with gross negligence and seeks damages for the loss of Harrison’s life.
“Our emotional response over this has been horrible,” said Shanoop Kothari said of his family, which also includes Harrison's 7-year-old sister, Hannah. “We’ve been devastated. We’ve been absolutely crushed.”
Representatives for the Triad Group did not respond to telephone and e-mail requests from msnbc.com to discuss the lawsuit or the recall. FDA spokesman Christopher Kelly said the 35-year-old family firm “did everything correctly” in notifying government authorities about the massive recall. Triad products are sold, often under private labels, in the U.S., Canada and Europe.
Kelly offered no futher details about the recall or whether other injuries have been reported.
Millions of products recalled
The company’s Jan. 5 voluntary notice said they were recalling all lots of pads, wipes, swabs and swabsticks “out of an abundance of caution,” and that they had received one report of a non-life-threatening skin infection linked to Bacillus cereus. However, the notice added that use of contaminated pads “could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.” There was no indication of how any wipes might have become contaminated.
The bacteria do have potential for devastating infections, according to Dr. Aaron Glatt, spokesman for the Infectious Diseases Society of America.
"It can be a pretty bad bug," said Glatt, president of St. Joseph Hospital in Bethpage, N.Y.
Bacillus cereus is a spore-forming bacterium found in soil and occasionally associated with foodborne illness. It can be resistant to heat and to disinfectant and has been known to survive standard sterilization procedures, Glatt said.
Harrison was not quite old enough to be vaccinated against bacterial meningitis when he had his surgery last fall, and even if he were, the recommended vaccine doesn’t protect against that strain of bacteria.
Harrison's mother, Sandra Kothari, said she worries that there may be more people injured or killed by the potentially tainted wipes and swabs, which were widely used in hospitals and sold in stores such as Walgreens and CVS.
“People buy alcohol pads and they last a long time in your bathroom. They’re sitting there now,” she said.
“I wouldn’t want any other mother to go what I’ve gone through.”
http://www.msnbc.msn.com/id/41588330...ases?GT1=43001
From the FDA Website
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.
Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination
Contact:
Eric Haertle, COO
262-538-2900
FOR IMMEDIATE RELEASE - January 5, 2011 - Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.
Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.
Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:
Cardinal Health
PSS Select
VersaPro
Boca/ Ultilet
Moore Medical
Walgreens
CVS
Conzellin
These products were distributed in the United States, Canada and Europe.
Specific customers distributing the product and selling it at the wholesale, hospital and retail pharmacy level have been notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession listing “Triad Group” as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund or call Triad Group Customer Service Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time: 262.538.2900.
DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call the Triad Group Customer Service listed below and we will issue you a return authorization number and make all return arrangements.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online:http://www.fda.gov/MedWatch/report.htm9
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10 Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.
http://www.fda.gov/safety/recalls/ucm239219.HTM
Millions of pads, swabs recalled because of same bacteria that killed 2-year-old boy
By JoNel Aleccia
Health writer
msnbc.com msnbc.com
updated 2/15/2011 8:21:03 AM ET
The parents of a 2-year-old Houston boy who died from a rare infection are suing makers of recalled alcohol prep products, claiming contaminated wipes and swabs transmitted bacteria that caused his fatal case of meningitis.
Sandra and Shanoop Kothari say their lively, dark-eyed toddler, Harrison, was recovering just fine from surgery to remove a benign cyst from near his brain and spinal cord last fall. But the day before he was set to be discharged after a week's stay, he developed a sudden and severe infection that worsened rapidly, causing multi-organ failure that led to Harrison’s death on Dec. 1, 2010.
Cultures showed he succumbed to acute bacterial meningitis caused by Bacillus cereus, bacteria typically found in rare food poisoning outbreaks, but not in hospital infections.
“They had no explanation as to how he contracted it,” said Sandra Kothari, 37, Harrison’s mother. “They know it’s rare in the hospital.”
Rare bacteria detected
For more than a month, the family grieved without knowing the cause of their loss. Then, on Jan. 5, a relative saw a notice posted online by the U.S. Food and Drug Administration. All lots of alcohol prep wipes, perhaps tens of millions of swabs and pads manufactured by the Triad Group, a Wisconsin medical product supplier, were being recalled.
The reason? Potential contamination with Bacillus cereus.
“These wipes were used in his care every single day, multiple times a day,” said Shanoop Kothari, Harrison’s father.
Officials at Children’s Memorial Hermann Hospital in Houston, where Harrison was treated, confirmed that the alcohol prep products they used were supplied by Triad, said the Kotharis’ lawyer Jim Purdue Jr. Samples of Triad products were taken from the room where Harrison stayed, he added. Shanoop Kothari said the recall offered terrible confirmation.
“We’re confident that that’s the cause,” said Kothari, 38, who works in the banking industry. “There was no other explanation that made any sort of sense. He contracted a very rare bacteria. These swatches were tainted with that bacteria.”
Lawyers filed a complaint Sunday in U.S. District Court in Houston. It charges the Triad Group of Hartland, Wis., with gross negligence and seeks damages for the loss of Harrison’s life.
“Our emotional response over this has been horrible,” said Shanoop Kothari said of his family, which also includes Harrison's 7-year-old sister, Hannah. “We’ve been devastated. We’ve been absolutely crushed.”
Representatives for the Triad Group did not respond to telephone and e-mail requests from msnbc.com to discuss the lawsuit or the recall. FDA spokesman Christopher Kelly said the 35-year-old family firm “did everything correctly” in notifying government authorities about the massive recall. Triad products are sold, often under private labels, in the U.S., Canada and Europe.
Kelly offered no futher details about the recall or whether other injuries have been reported.
Millions of products recalled
The company’s Jan. 5 voluntary notice said they were recalling all lots of pads, wipes, swabs and swabsticks “out of an abundance of caution,” and that they had received one report of a non-life-threatening skin infection linked to Bacillus cereus. However, the notice added that use of contaminated pads “could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.” There was no indication of how any wipes might have become contaminated.
The bacteria do have potential for devastating infections, according to Dr. Aaron Glatt, spokesman for the Infectious Diseases Society of America.
"It can be a pretty bad bug," said Glatt, president of St. Joseph Hospital in Bethpage, N.Y.
Bacillus cereus is a spore-forming bacterium found in soil and occasionally associated with foodborne illness. It can be resistant to heat and to disinfectant and has been known to survive standard sterilization procedures, Glatt said.
Harrison was not quite old enough to be vaccinated against bacterial meningitis when he had his surgery last fall, and even if he were, the recommended vaccine doesn’t protect against that strain of bacteria.
Harrison's mother, Sandra Kothari, said she worries that there may be more people injured or killed by the potentially tainted wipes and swabs, which were widely used in hospitals and sold in stores such as Walgreens and CVS.
“People buy alcohol pads and they last a long time in your bathroom. They’re sitting there now,” she said.
“I wouldn’t want any other mother to go what I’ve gone through.”
http://www.msnbc.msn.com/id/41588330...ases?GT1=43001
From the FDA Website
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.
Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination
Contact:
Eric Haertle, COO
262-538-2900
FOR IMMEDIATE RELEASE - January 5, 2011 - Hartland, Wisconsin, Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.
Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.
Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:
Cardinal Health
PSS Select
VersaPro
Boca/ Ultilet
Moore Medical
Walgreens
CVS
Conzellin
These products were distributed in the United States, Canada and Europe.
Specific customers distributing the product and selling it at the wholesale, hospital and retail pharmacy level have been notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession listing “Triad Group” as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund or call Triad Group Customer Service Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time: 262.538.2900.
DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call the Triad Group Customer Service listed below and we will issue you a return authorization number and make all return arrangements.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online:http://www.fda.gov/MedWatch/report.htm9
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10 Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.
http://www.fda.gov/safety/recalls/ucm239219.HTM
Cummins Guru
Joined: Feb 2008
Posts: 4,191
Likes: 65
From: Sunny Southern California Land of Fruits and Nuts
Thanks you for posting I will pass it on. Most likely products all made in CHINA. I would also like to add anyone that if you are storing diesel fuel for long periods of time beware flesh eating bacteria known to thrive in old diesel fuel. If the fuel has changed in color and has turned dark or black do not get it on your skin. There is no way to stop this bacteria other then amputation of infected part. Serious stuff guys so be careful of diesel that has turned black or dark in color.
Bill
Bill
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