Tuesday, February 22, 2011

PSA: Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Swabs and Swab Sticks Due to Potential Microbial Contamination

Alcohol prep pads, swabs and swab sticks have been voluntarily recalled by the manufacturer, Triad Group, due to potential contamination with an objectionable organism, Bacillus cereus. The recalled products can be identified by either "Triad Group"listed as the manufacturer, or products manufactured for third-party use will use any of the following names: Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, or Conzellin. These products were distributed in the United States and internationally. The recall applies to both sterile and unsterile products.

Alcohol prep pads, swabs and swab sticks are used to disinfect an area of skin prior to injection. Use of contaminated products could lead to life-threatening infections, especially in at-risk populations including immune suppressed and surgical patients. To date, one non-life-threatening skin infection has been reported.
If you have a supply of these products, do not use them, but return them to the place of purchase for a full refund.

The press release for the recalled products is available at the following web link: http://www.fda.gov/Safety/Recalls/ucm239219.htm
 
Updates of the original press release are available at the following web link:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm
 
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 (1-800-332-0178)

No comments:

Post a Comment