Surgical Convenience Kits Recalled for Included 3M Surgical Drapes
ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II recall with no reported injuries or illnesses. The kits contained 3M surgical drapes that were separately recalled, but the source does not specify the underlying hazard or report any patient complications.
Plain-English summary
ROi CPS LLC is recalling regard DAVINCI PACK surgical convenience kits (Item Number 880132023) used in gastric surgery procedures. The company distributed 228 kits in Louisiana, Missouri, North Carolina, and Florida.
The kits were recalled because they contained 3M surgical drapes that were subject to a separate recall. The specific hazard associated with the 3M drapes is not detailed in this notice.
Affected kits carry the following lot numbers with their expiration dates: Lot 90987 (expiration 12/28/2023), Lot 91804 (expiration 3/18/2024), and Lot 92715 (expiration 6/6/2024). Healthcare facilities that received these kits should verify their inventory and contact the manufacturer for guidance.
If you have received any of these kits, contact ROi CPS LLC for return or replacement instructions. Do not use the surgical drapes included in these kits. No patient injuries have been reported.
The recalled product
- Product
- regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 228
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 (7)
- UDI/DI 10194717113119
- Lot Numbers: 90987
- exp 12/28/2023
- 91804
- exp 3/18/2024
- 92715
- exp 6/6/2024
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 →- SevereNewborn 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 · recalled component
See all →- ModerateMedline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
FDA (Devices) · 2024-12-11
- HighMedline recalls surgical kits containing Stryker smoke evacuation pencil component
FDA (Devices) · 2024-12-11
- HighMEDLINE medical convenience kits recalled for defective component
FDA (Devices) · 2024-12-11
- HighFDA Recalls 9,489 Surgical Instrument Kits for Recalled 3M Drapes
FDA (Devices) · 2023-01-11
- ModerateDeRoyal Spinal Fusion Packs Recalled Due to Affected Sterile Drapes
FDA (Devices) · 2022-12-21
Similar recalls
- CriticalSurgical Convenience Kit Recalled Due to Defective Component
FDA (Devices) · 2024-01-24
- HighSurgical Convenience Kits Recalled for Separating Light Handle Covers
FDA (Devices) · 2023-05-03
- HighMedical Convenience Kit Recalled for Defective Dermatome Blades
FDA (Devices) · 2023-10-11
- HighSurgical Convenience Kits Recalled Due to Separating Light Handle Covers
FDA (Devices) · 2023-05-03
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighCardiovascular Convenience Kit Recalled for Inadequate Chest Drain Instructions
FDA (Devices) · 2023-11-22