Steris SixCess Challenge Pack Recalled for Incorrect Chemical Indicators
Steris Corporation is recalling 619 boxes of Verify SixCess Challenge Pack due to incorrect chemical indicators in the packaging. This sterilization validation device is distributed across 31 U.S. states.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls are typically scored 1 or 2. No illnesses or injuries have been reported. The issue is a product defect with incorrect chemical indicators that prevents proper function, but presents theoretical rather than documented harm.
Plain-English summary
Steris Corporation is recalling 619 boxes of Verify SixCess Challenge Pack (Lot 3411228A, Item Number: LCC003, UDI-DI: 10724995088955) due to incorrect chemical indicators in the packaging.
The Verify SixCess Challenge Pack is designed to confirm that critical parameters of steam sterilization have been reached. The product was distributed in the United States across the following 31 states: Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Nebraska, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming.
The incorrect chemical indicators may prevent proper validation of sterilization parameters in accordance with the device's intended use. Users who have received affected units from the recalled lot should contact Steris Corporation for guidance on product replacement or corrective action.
The recalled product
- Product
- Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
- Manufacturer
- Steris Corporation Hopkins Facility
- Affected units
- 619
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI (GTIN): 10724995088955 Item Number: LCC003
- Lot 3411228A
Distribution
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