DeRoyal BASIC EYE PACK Medical Device Voluntary Recall
DeRoyal BASIC EYE PACK (Lot 57389942) was voluntarily recalled as a Class II medical device on November 3, 2022. The specific reason for recall is not disclosed in the FDA notice.
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: FDA Class II classification with voluntary, firm-initiated recall. No illnesses or injuries reported in the notice. Specific hazard is not disclosed in the source material, limiting severity assessment to moderate level.
Plain-English summary
DeRoyal BASIC EYE PACK (REF 89-9233.08) was voluntarily recalled by manufacturer DeRoyal Industries Inc on November 3, 2022. The recall involves 60 kits with Lot Number 57389942 (expiration September 1, 2024).
The FDA classified this as a Class II recall, indicating potential health consequences, though the specific reason for the recall is not disclosed in the available FDA notice.
The product was distributed to healthcare facilities and suppliers across 23 U.S. states: 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.
Healthcare providers and patients who have received this product should check if they have Lot 57389942 and contact the manufacturer for further information regarding the recall status and any necessary replacement procedures.
The recalled product
- Product
- DeRoyal BASIC EYE PACK, REF 89-9233.08
- 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 (1)
- Lot Numbers: Lot 57389942 exp 9/1/2024
Distribution
Distribution scope not specified by the agency.
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