FDA Class II Recall of Surgical Convenience Kits with Recalled 3M Surgical Drapes
ROi CPS LLC is recalling 20 surgical convenience kits distributed in LA, MO, NC, and FL because they contain 3M surgical drapes that were subsequently recalled.
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 precautionary recall based on the inclusion of a defective component (3M surgical drapes). No illnesses or injuries have been reported in connection with this recall. The recall is secondary, addressing the presence of an already-recalled component within the kit.
Plain-English summary
ROi CPS LLC is recalling 20 regard ACDF surgical convenience kits (Item Number 800246008, Lot 91760, expiring November 8, 2023) distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. The kits are being recalled because they contain 3M surgical drapes that were subsequently recalled by the manufacturer.
Affected kits carry UDI/DI 10194717101314. Healthcare facilities and surgical centers that have received these kits should discontinue use and contact ROi CPS LLC for instructions on product return or replacement.
The recalled product
- Product
- regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- surgical-drape-defect
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)
- UDI/DI 10194717101314
- Lot Numbers: 91760
- exp 11/8/2023
Distribution
Distributed in 4 states:
- FL
- LA
- MO
- NC
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