DeRoyal SPINE PACK procedure kits recalled due to included 3M Steri Drapes
DeRoyal Industries is recalling SPINE PACK procedure kits that contain 3M Health Care Steri Drapes, which have been previously recalled. The recalled kits were distributed to medical facilities across multiple U.S. states.
What this means for you
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 an FDA Class II medical device recall without reported illnesses or injuries. The recall is precautionary in nature, triggered by the inclusion of a previously recalled component, fitting the rubric criterion for voluntary precautionary recalls.
Plain-English summary
DeRoyal Industries Inc is recalling DeRoyal SPINE PACK procedure kits (Reference 89-8361.09) due to the inclusion of 3M Health Care Steri Drapes that have been subject to recall.
The affected lot is Lot 57005620 with expiration date 09/01/2026. A total of 144 kits were distributed to healthcare facilities across the United States, including 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 SPINE PACK procedure kits contain 3M Health Care Steri Drapes that have been recalled. As a result, DeRoyal Industries is recalling the entire procedure kits.
Healthcare facilities that received these kits should refer to instructions from DeRoyal Industries Inc and the FDA regarding the recall.
The recalled product
- Product
- DeRoyal SPINE PACK, REF 89-8361.09
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- recalled-component
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 57005620 exp 09/01/2026
Distribution
Distribution scope not specified by the agency.
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