DeRoyal Oral Procedure Packs Recalled for Affected Steri Drapes
DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a product containing a component with an established defect. Although no illnesses or injuries are reported in the source, the risk-of-harm nature of a surgical procedure pack with a defective medical device component warrants a High severity rating.
Plain-English summary
DeRoyal Industries Inc is recalling MAJOR ORAL PACK RF (Reference 89-3936.15) procedure kits because they contain 3M Health Care Steri Drapes that have been subject to recall. The recall involves 828 kits.
The affected lots include seven batches with expiration dates ranging from January 2024 through October 2024. Healthcare facilities in Alabama, Arizona, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin received the affected kits.
Healthcare providers who have received these products should stop using them and contact DeRoyal Industries for instructions on returning or replacing the kits. The FDA is monitoring this recall.
The recalled product
- Product
- DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- defective-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 (7)
- Lot Numbers: Lot 56185163 exp 2/1/2024
- Lot 56390466 exp 2/1/2024
- Lot 56616859 exp 2/1/2024
- Lot 57390901 exp 1/1/2024
- Lot 57466813 exp 10/1/2024
- Lot 57589987 exp 6/1/2024
- Lot 57674444 exp 6/1/2024
Distribution
Distribution scope not specified by the agency.
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