DeRoyal Minor Oral and ENT Procedure Packs Recalled for Defective Steri Drapes
DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.
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: FDA Class II medical device recall. No illnesses or injuries reported in the source. The affected surgical drapes are used to maintain sterile fields during procedures; a defect could compromise sterility and result in infection, but no actual harm has been documented.
Plain-English summary
DeRoyal Industries Inc is recalling 78 kits of its Minor Oral/ENT Procedure Pack (model REF 89-2576.15, Lot 57589637, expiration June 1, 2023) because the packs contain 3M Health Care Steri Drapes that have been separately recalled.
The affected kits were distributed to healthcare facilities across 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.
Healthcare practitioners and facility personnel should immediately discontinue use of the affected packs and contact DeRoyal Industries Inc for return instructions, replacement options, or additional information regarding this recall.
The recalled product
- Product
- DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Drapes
- Hazard
- sterilization
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 57589637
- exp 6/1/2023
Distribution
Distribution scope not specified by the agency.
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