Medical Device Recall: DeRoyal NEURO SPINE BACK PACK Kit
DeRoyal Industries Inc is recalling 180 kits of the NEURO SPINE BACK PACK PGYBK distributed across multiple U.S. states. The specific reason for the recall is not documented in the agency filing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: Class II medical device recall with no reported illnesses or injuries. The specific defect is not documented in the recall notice, preventing risk assessment.
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of 180 kits of the NEURO SPINE BACK PACK PGYBK (REF 89-10853.01) beginning November 3, 2022. The affected product corresponds to lot number 57187574 with an expiration date of April 1, 2024.
The specific defect or hazard prompting the recall is not detailed in the available recall documentation. The product was distributed 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.
Consumers who possess affected kits should contact DeRoyal Industries Inc for instructions on proper handling or replacement. Healthcare facilities and distributors should verify their inventory against the lot number and expiration date to identify affected units.
The recalled product
- Product
- DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Spinal Support
- Affected units
- 180
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 57187574 exp 4/1/2024
Distribution
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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