DeRoyal EYE TRAY Procedure Packs Recalled Due to 3M Steri Drape Recall
DeRoyal Industries is recalling EYE TRAY procedure packs containing recalled 3M Health Care Steri Drapes. The recall affects 180 kits distributed across 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 medical device recall with no reported illnesses or injuries documented in the source. The specific hazard related to the recalled 3M component is not detailed in this notice.
Plain-English summary
DeRoyal Industries Inc. is recalling DeRoyal EYE TRAY PGYBK (REF 89-7978.02) procedure packs because they contain 3M Health Care Steri Drapes that have been recalled by the manufacturer.
A total of 180 procedure packs containing the affected component were distributed throughout the United States. Distribution included the following 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 lot number is Lot 56394686, which expires July 1, 2024.
Users who have received these procedure packs should immediately discontinue use of the affected lot. Contact DeRoyal Industries Inc. for instructions on returning or replacing the product.
The recalled product
- Product
- DeRoyal EYE TRAY PGYBK, REF 89-7978.02
- Manufacturer
- DeRoyal Industries Inc
- 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 56394686 exp 7/1/2024
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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