DeRoyal Cannulated Hip Packs Recalled for Defective Steri Drapes
DeRoyal Industries is recalling 108 kits of Cannulated Hip Procedure Packs because they contain 3M Steri Drapes that have been recalled. Affected lots were distributed across 23 U.S. 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 with no reported illnesses or injuries mentioned in the source text. The recall is secondary—based on contained components recalled by another manufacturer—with the specific hazard unspecified. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
DeRoyal Industries Inc is recalling 108 kits of its CANNULTED HIP PACK CSM (reference 89-6977.09), a surgical procedure pack used in medical procedures. The packs contain 3M Health Care Steri Drapes that have been recalled by their manufacturer.
The reason for the Steri Drape recall was not specified in this notice, but the procedure packs are being recalled because they contain the affected components.
Affected product was distributed to healthcare facilities in 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. Two lot numbers are involved: Lot 56183862 (expiration 3/1/2025) and Lot 56613244 (expiration 9/1/2025).
Healthcare providers and customers with affected kits should discontinue use and contact DeRoyal Industries Inc for instructions regarding return or replacement.
The recalled product
- Product
- DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
- 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 (2)
- Lot Numbers: Lot 56183862 exp 3/1/2025
- Lot 56613244 exp 9/1/2025
Distribution
Distribution scope not specified by the agency.
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