DeRoyal shoulder procedure packs recalled for defective 3M Steri Drapes
DeRoyal OPEN SHOULDER PROCEDURE PACK RF kits are being recalled because they contain 3M Health Care Steri Drapes that have been subject to recall. A total of 42 kits are affected.
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: This is a Class II FDA recall with no reported illnesses, injuries, or deaths. It is a precautionary secondary recall due to the inclusion of a previously recalled component, fitting the criteria for Moderate severity.
Plain-English summary
DeRoyal Industries Inc is recalling its OPEN SHOULDER PROCEDURE PACK RF (Reference Number 89-6629.09) due to the inclusion of affected 3M Health Care Steri Drapes. A total of 42 kits are affected.
The recalled lot numbers are: Lot 57391516 (expiration 11/1/2024) and Lot 57749549 (expiration 8/1/2024). These procedure packs were distributed to healthcare 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.
Healthcare providers and medical facilities should immediately stop using the affected procedure packs. Facilities in possession of these items should contact DeRoyal Industries Inc for instructions on returning or disposing of the recalled products.
The recalled product
- Product
- DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 42
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 57391516 exp 11/1/2024
- Lot 57749549 exp 8/1/2024
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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