DeRoyal BASIC PACK surgical kit voluntary medical device recall
DeRoyal Industries Inc is voluntarily recalling 130 kits of the DeRoyal BASIC PACK medical device across 23 U.S. states due to an FDA Class II recall.
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 recall initiated voluntarily by the manufacturer with no reported illnesses or injuries. Voluntary precautionary recalls without documented harm fall within the Moderate severity category.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling 130 kits of the DeRoyal BASIC PACK, REF 89-8633.07. The FDA classified this as a Class II recall (recall number Z-0618-2023).
The affected medical device kits are 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.
Three lot numbers are affected: Lot 56188938, Lot 57022930, and Lot 57825222, all with expiration date June 1, 2024. DeRoyal Industries Inc initiated this voluntary recall and has notified healthcare facilities and distributors through email, fax, letters, press releases, telephone, and direct visits. No illnesses or injuries have been reported in the available source material.
The recalled product
- Product
- DeRoyal BASIC PACK, REF 89-8633.07
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 130
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 (3)
- Lot Numbers: Lot 56188938 exp 6/1/2024
- Lot 57022930 exp 6/1/2024
- Lot 57825222 exp 6/1/2024
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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