DeRoyal Ophtalmology Procedure Packs with Recalled Steri Drapes
DeRoyal Industries is recalling 90 ophtalmology procedure kits because they contain 3M Steri Drapes that have been recalled. The affected kits were distributed 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 with no reported illnesses or injuries. The recall is initiated due to the inclusion of a component that has been recalled by the supplier, rather than an identified defect in the DeRoyal product itself.
Plain-English summary
DeRoyal Industries Inc is recalling 90 GEO-MED OPHTALMOLOGY CSTM PCK procedure kits (Reference 89-6387.08). This recall is initiated because the procedure kits contain 3M Health Care Steri Drapes that have been subject to recall.
The affected kits were distributed to healthcare facilities across multiple 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 affected lots are Lot 56065591 with an expiration date of 8/1/1024 and Lot 56618230 with an expiration date of 9/1/2024. Additional information regarding this recall is available through the U.S. Food and Drug Administration.
The recalled product
- Product
- GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
- 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 (2)
- Lot Numbers: Lot 56065591 exp 8/1/1024
- Lot 56618230 exp 9/1/2024
Distribution
Distribution scope not specified by the agency.
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