Medical Device Shoulder Pack Voluntarily Recalled by DeRoyal Industries
DeRoyal Industries voluntarily recalled 876 kits of its Shoulder Pack medical device distributed to 23 states. The reason for the recall was not disclosed in FDA records.
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 Class II FDA medical device recall initiated voluntarily by the manufacturer with no reported injuries or illnesses documented. Voluntary precautionary recalls with no disclosed specific hazard or reported harm warrant a Moderate severity rating per the rubric.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 876 kits of its Shoulder Pack (Model 89-6830.13), a medical device distributed across 23 U.S. states beginning November 3, 2022. The specific reason for the recall was not disclosed in the FDA's public database record.
The affected devices were distributed to healthcare facilities and other locations 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.
Consumers and healthcare facilities in possession of this device should verify their inventory against the following lot numbers: Lot 56184005 (expires 11/1/2023), Lot 56254392 (expires 10/1/2023), Lot 56777927 (expires 1/1/2024), Lot 57391031 (expires 2/1/2024), and Lot 57684204 (expires 5/1/2024). Those with affected units should contact DeRoyal Industries directly for further guidance.
The recalled product
- Product
- DeRoyal SHOULDER PACK, REF 89-6830.13
- 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 56184005 exp 11/1/2023
- Lot 56254392 exp 10/1/2023
- Lot 56777927 exp 1/1/2024
- Lot 57391031 exp 2/1/2024
- Lot 57684204 exp 5/1/2024
Distribution
Distribution scope not specified by the agency.
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