DeRoyal Endovenous Procedure Packs Recalled Due to Affected Steri Drapes
DeRoyal is recalling 88 endovenous procedure packs containing 3M Health Care Steri Drapes that have been recalled. The packs were distributed across 23 US states; consumers should stop using them immediately.
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 medical device recall with no reported illnesses, injuries, or deaths. The source does not specify the nature of the defect in the Steri Drapes, indicating a precautionary secondary recall.
Plain-English summary
DeRoyal Industries Inc is recalling 88 endovenous procedure packs (model ENDOVENOUS PACK, REF 89-7762.05) because they contain 3M Health Care Steri Drapes that have been recalled.
The affected lots are: Lot 54880154 (expiration 12/1/2023) and Lot 57186299 (expiration 10/1/2024). The packs were distributed to medical facilities 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 who have received these procedure packs should stop using them immediately. Contact DeRoyal Industries Inc for instructions on how to handle the affected product.
The recalled product
- Product
- DeRoyal ENDOVENOUS PACK, REF 89-7762.05
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 88
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 54880154 exp 12/1/2023
- Lot 57186299 exp 10/1/2024
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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