DeRoyal Cotton Adjustable Limb Holders Recalled for Moldy Smell
DeRoyal Industries is recalling 8,962 pairs of cotton adjustable limb holders due to a moldy smell. The products were distributed in the US and Argentina.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II. The hazard is a moldy smell, which is a quality defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
DeRoyal Industries Inc is recalling 8,962 pairs of DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017. The recall is due to a moldy smell in the product. These limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others.
The affected products are identified by lot numbers 1143442 and 1161762. The products were distributed nationwide in the United States, specifically in the states of Florida, North Carolina, Iowa, Alabama, Illinois, and Texas, as well as in Argentina.
Consumers should stop using the affected limb holders and contact DeRoyal Industries Inc for further instructions or a refund.
The recalled product
- Product
- DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Restraints
- Affected units
- 8,962
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 numbers 1143442 and 1161762
Distribution
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