FDA Class II recall issued for DeRoyal BASIC EYE PACK medical device
DeRoyal Industries Inc recalled 45 kits of its BASIC EYE PACK medical device distributed to healthcare facilities across the United States. The FDA classified this as a voluntary Class II recall.
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: This is an FDA Class II voluntary recall with no reported adverse events, illnesses, or injuries. Voluntary Class II recalls without documented harm are typically classified as Moderate.
Plain-English summary
DeRoyal Industries Inc has issued a voluntary Class II recall of the BASIC EYE PACK medical device (model REF 89-8337.08). The recall affects 45 kits distributed to healthcare facilities across the United States, with documented distribution in Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The specific reason for this recall is not provided in the FDA documentation. The affected product lot numbers are Lot 56386740 exp 8/1/2024 and Lot 55970688 exp 08/01/2024. Healthcare providers and facilities in possession of this product should contact DeRoyal Industries Inc for further information and instructions regarding the recall.
The recalled product
- Product
- DeRoyal BASIC EYE PACK, REF 89-8337.08
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Eye Care
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)
- Lot Numbers: Lot 56386740 exp 8/1/2024
- Lot 55970688 exp 08/01/2024
Distribution
Distribution scope not specified by the agency.
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