Medical Device Recall: GEO-MED Upper Extremity Pack Kit
DeRoyal Industries initiated a voluntary recall of 243 GEO-MED Upper Extremity Pack kits distributed across 23 US states. The specific reason for the recall is not available in the source material.
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 a voluntary, firm-initiated FDA Class II recall with no reported illnesses or injuries stated in the source. Per the rubric, voluntary precautionary recalls are classified as Moderate (2), and the absence of reported adverse events supports this lower severity assessment.
Plain-English summary
DeRoyal Industries Inc. has initiated a voluntary recall of the GEO-MED UPPER EXTREMITY PACK, REF 89-8253.02, affecting 243 kits. The recalled product was distributed across 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.
The recall involves five specific lot numbers with varying expiration dates: Lot 56189375 (expires 10/1/2024), Lot 56392381 (expires 10/1/2024), Lot 56618504 (expires 11/1/2024), Lot 57392455 (expires 2/1/2025), and Lot 5775963 (expires 4/1/2025). DeRoyal initiated the recall on November 3, 2022.
The specific reason for this Class II recall is not provided in the available source material. Healthcare facilities and distributors who received products matching these lot numbers should verify their stock and contact DeRoyal Industries or the FDA for further information regarding the recall.
The recalled product
- Product
- GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
- Manufacturer
- DeRoyal Industries Inc
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 (5)
- Lot Numbers: Lot 56189375 exp 10/1/2024
- Lot 56392381 exp 10/1/2024
- Lot 56618504 exp 11/1/2024
- Lot 57392455 exp 2/1/2025
- Lot 5775963 exp 4/1/2025
Distribution
Distribution scope not specified by the agency.
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