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
- Affected units
- 20
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
Part of a larger recall action
This product is one of 40 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 40 products in this recall →Related recalls
Same manufacturer · ROi CPS LLC
See all →- HighNewborn Resuscitator Kit Recalled for Inline Spring Defect
FDA (Devices) · 2025-02-12
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighRegard Kit Decanters Recalled for Defective Sterile Packaging
FDA (Devices) · 2024-08-28
- CriticalSurgical Convenience Kit Recalled Due to Defective Component
FDA (Devices) · 2024-01-24
- SevereRegard Dressing Change Kit Recalled Due to Defective Irrigation Solution
FDA (Devices) · 2024-01-10
Same hazard · surgical drape defect
See all →- HighDeRoyal Shoulder Arthroscopy Procedure Packs Recalled Due to Defective Surgical Drapes
FDA (Devices) · 2022-12-21
- HighRegard Retinal Pack surgical kits recalled for defective 3M drapes
FDA (Devices) · 2022-11-30
- HighHip Arthroplasty Surgical Convenience Kits Recalled Due to Defective 3M Drapes
FDA (Devices) · 2022-11-30
- ModerateEye Surgery Convenience Kits Recalled for Defective Surgical Drapes
FDA (Devices) · 2022-11-30
- HighSurgical Convenience Kits Recalled Due to Recalled Surgical Drapes
FDA (Devices) · 2022-11-30