DeRoyal Procedure Packs Recalled Due to Included 3M Steri Drapes
DeRoyal Industries recalls EYE PACK procedure kits because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 156 kits 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: FDA Class II medical device recall for procedure kits containing a known-recalled medical device component. No illnesses or injuries reported in source text, but the inclusion of recalled Steri Drapes in surgical procedure kits poses a potential risk of harm.
Plain-English summary
DeRoyal Industries is recalling the EYE PACK (Reference 89-4051.09), a medical procedure kit, because it contains 3M Health Care Steri Drapes that have been recalled. A total of 156 kits are affected.
The affected kits were distributed across 23 U.S. 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 lot numbers are: Lot 56778647 (expiration 4/1/2023), Lot 57190263 (expiration 4/1/2023), and Lot 57750460 (expiration 4/3/2023).
Healthcare facilities and users in possession of these procedure packs should stop using them and contact DeRoyal Industries with any questions or to arrange replacement.
The recalled product
- Product
- DeRoyal EYE PACK, REF 89-4051.09
- 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 (3)
- Lot Numbers: Lot 56778647 exp 4/1/2023
- Lot 57190263 exp 4/1/2023
- Lot 57750460 exp 4/3/2023
Distribution
Distribution scope not specified by the agency.
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