Surgical convenience kits recalled due to included recalled 3M drapes
Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.
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 3/5 (High).
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 recall of a medical device. No illnesses or injuries are reported in the recall notice. The product is a surgical convenience kit containing recalled surgical drapes, presenting a potential risk in medical contexts, meeting the criteria for High severity where injury has not yet been reported.
Plain-English summary
Regarding NEURO PACK surgical convenience kits (Item Number 800040012, UDI/DI 10194717112501) manufactured by ROi CPS LLC have been recalled. The kits were distributed containing 3M surgical drapes that are subject to a separate recall.
The affected product was distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. A total of 69 kits were involved in the distribution.
Affected lot numbers are 91643 (expiration 7/1/2023) and 91242 (expiration 8/12/2023). The recall applies to product code NU00278L.
The recalled product
- Product
- regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 69
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 (5)
- UDI/DI 10194717112501
- Lot Numbers: 91643
- exp 7/1/2023
- 91242
- exp 8/12/2023
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 →- 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
- ModerateDeRoyal BASIC NEURO PACK procedure kits recalled due to defective Steri Drape component
FDA (Devices) · 2022-12-21
- ModerateDeRoyal BASIC NEURO PACK kits recalled due to 3M Steri Drapes recall
FDA (Devices) · 2022-12-21
- SevereCustomed Recalls Neuro Pack Surgical Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- HighDeRoyal procedure packs recalled for containing affected Steri Drapes
FDA (Devices) · 2022-12-21
- HighDeRoyal Procedure Packs Recalled for Defective Steri Drape Components
FDA (Devices) · 2022-12-21