DeRoyal Foot Pack Medical Device Class II Recall
DeRoyal Industries has initiated a voluntary Class II recall of 217 kits of its DeRoyal Foot Pack (REF 89-9252.07). The recall affects multiple U.S. states.
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: FDA Class II device recall voluntarily initiated by the firm with no reported illnesses or injuries, consistent with a precautionary measure.
Plain-English summary
DeRoyal Industries Inc, based in Powell, Tennessee, has voluntarily recalled 217 kits of the DeRoyal FOOT PACK (REF 89-9252.07), a medical device. The recall was initiated on November 3, 2022, and remains ongoing as of the December 21, 2022 report date.
The recall affects the following 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. The affected products carry the following lot numbers: Lot 57171601 (expiration 10/1/2024) and Lot 57505843 (expiration 1/1/2025).
No illnesses or injuries have been reported. The company notified healthcare facilities and customers through email, fax, letter, press release, telephone, and direct visits. Facilities and individuals who have received these products should verify lot numbers and discontinue use of affected units.
The recalled product
- Product
- DeRoyal FOOT PACK, REF 89-9252.07
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Foot Pack
- Affected units
- 217
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 57171601 exp 10/1/2024
- Lot 57505843 exp 1/1/2025
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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