​The California Department of Public Health is advising all facilities to take the following action based on an urgent message from the FDA.

The FDA has requested that facilities immediately remove all alcohol prep pads, alcohol swabs and alcohol swabsticks supplied by the Triad Group from your inventory due to a voluntary recall by the Triad Group.

This recall involves 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. These products have been 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 if the products are manufactured for a third party, using the names listed below in their packaging:

See the FDA web site (www.fda.gov) for more information.

RECOMMENDATION: If a consumer or facility has any of these products in their possession, they should not use the product and should return it to the place it was purchased.

Consumers or facilities with questions should call Triad Group Customer Service at 1-262-538-2900.

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 by:

• Completing and submitting the report Online at: 
  FDA - MedWatch Online Voluntary Reporting Form
• Downloading the form FDA 3500 at:
  FDA 3500
• or call 1-800-332-1088 to request a FDA 3500 reporting form.

Completed forms should be sent as indicated on the pre-addressed form or submitted by fax to 1-800-FDA-0178.

Thank you for your prompt attention.

Sincerely,

Original Signed by Pamela Dickfoss

Pamela Dickfoss
Acting Deputy Director

cc:

California Hospital Association
California Conference of Local Health Officers
CDPH Emergency Preparedness Office
CDPH Licensing and Certification Program
CDPH Division of Communicable Disease Control
HAI Advisory Committee