Surgical Convenience Kits Recalled Due to Defective 3M Surgical Drapes
ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits containing 3M surgical drapes that were previously recalled. Affected units were distributed to 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 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: FDA Class II medical device recall with no reported illnesses or injuries. Surgical device kits are risk-of-harm products, meeting the rubric criterion for High (score 3), but the lack of reported injury prevents a higher classification.
Plain-English summary
ROi CPS LLC is recalling regard BASIC NEURO surgical convenience kits (NU00259S, Item 800021019, UDI/DI 10194717115397, Lot 92346, expiration 2/14/2024) because they contain 3M surgical drapes that were subsequently recalled.
A total of 160 units were distributed to Louisiana, Missouri, North Carolina, and Florida. These kits are used in neurosurgery procedures.
Healthcare facilities and professionals who received these kits should discontinue use and contact ROi CPS LLC for further instructions regarding replacement or return of the affected product.
The recalled product
- Product
- regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 160
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 10194717115397
- Lot Numbers: 92346
- exp 2/14/2024
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.
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