DeRoyal Facial Pack Medical Device Under Voluntary FDA Recall
DeRoyal Industries has voluntarily recalled 35 kits of DeRoyal FACIAL PACK PGYBK medical devices. The FDA classified the recall as Class II, and it remains ongoing.
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 medical device recall initiated voluntarily by the manufacturer with no reported illnesses or injuries. It fits the rubric category of a voluntary precautionary recall.
Plain-English summary
DeRoyal Industries Inc is recalling 35 kits of DeRoyal FACIAL PACK PGYBK medical devices (Reference 89-10007.03). The recall includes two affected lots: Lot 55968449 with expiration date January 1, 2024, and Lot 56619751 with expiration date April 1, 2024.
The manufacturer initiated this recall voluntarily on November 3, 2022. The FDA classified it as Class II. The specific reason for the recall has not been disclosed in publicly available records.
The affected products were distributed to healthcare facilities in 23 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 organizations that received these devices should contact DeRoyal Industries Inc for recall instructions. This recall remains ongoing.
The recalled product
- Product
- DeRoyal FACIAL PACK PGYBK, REF 89-10007.03
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- medical-device-defect
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 55968449 exp 1/1/2024
- Lot 56619751 exp 4/1/2024
Distribution
Distribution scope not specified by the agency.
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