Resource Optimization Recalls Regard Migrating Indicator Strips for Malfunction
Resource Optimization & Innovation LLC is recalling Regard Migrating Indicator Strips because they malfunction and fail to reach the accept window during use.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a functional malfunction of a monitoring device without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Resource Optimization & Innovation LLC is voluntarily recalling Regard Migrating Indicator Strips, REORDER # 335576REG. The product is an integrating indicator designed to chemically react with the critical parameters of steam sterilization cycles.
The recall was initiated after the firm received reports from customers that the indicators malfunction and do not go into the "accept" window at the time of use. This failure could result in inaccurate sterilization monitoring.
The recall affects 66 cases of 12,000 units per case, specifically Lot 719. The product was distributed nationwide in the United States, including in the states of Missouri, North Carolina, Arkansas, and Oklahoma. Users should stop using the affected indicators and contact the recalling firm for instructions.
The recalled product
- Product
- regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
- Manufacturer
- Resource Optimization & Innovation LLC
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 (1)
- Lot 719
Distribution
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