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Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to

Potential Microbial Contamination

Sold by Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Medical,

Walgreens, CVS, Conzellin

[Posted 01/06/2011]

AUDIENCE: Pharmacy, Consumer

ISSUE:

Triad Group, a manufacturer of over-the-counter products and FDA

notified healthcare professionals and patients of the recall involving

all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks

manufactured by Triad but sold as private labels at the consumer level.

This recall has been initiated due to concerns about potential

contamination of the products with Bacillus cereus. This recall involves

those products marked as STERILE as well as non-sterile products. Use

of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks

could lead to life-threatening infections, especially in at-risk populations,

including immune suppressed and surgical patients.

BACKGROUND:

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,

Medical, Walgreens, CVS, Conzellin.

RECOMMENDATION:

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.

Healthcare

professionals and patients are encouraged to report adverse events or

side effects related to the use of these products to the FDA's MedWatch

Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or

call 1-800-332-1088 to request a reporting form, then complete and

return to the address on the pre-addressed form, or submit by fax to

1-800-FDA-0178

 

[01/06/2011 - Press Release - Triad Group]    

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm239319.htm

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