DeRoyal Extremity Trays Recalled Due to Affected 3M Steri Drapes
DeRoyal is recalling its EXTREMITY TRAY procedure packs because they contain recalled 3M Health Care Steri Drapes. The affected kits are 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 classification for a medical device recall with no reported illnesses or injuries in the source material. This is a precautionary recall due to affected components from a supplier.
Plain-English summary
DeRoyal Industries Inc is recalling DeRoyal EXTREMITY TRAY PGYBK procedure packs (Reference 89-4081.07) because they contain 3M Health Care Steri Drapes that have been recalled.
The recall affects 130 kits distributed to healthcare facilities in 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. The affected lots are Lot 56394918 (expiration 11/3/2024) and Lot 56778591 (expiration 12/1/2024).
Healthcare facilities should check their inventory using the lot numbers provided and contact DeRoyal Industries Inc for further guidance.
The recalled product
- Product
- DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- 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 (2)
- Lot Numbers: Lot 56394918 exp 11/3/2024
- Lot 56778591 exp 12/1/2024
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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