Neurosurgery convenience kits recalled due to included recalled surgical drapes
ROi CPS LLC is recalling 248 regard NEURO TRAY neurosurgery convenience kits because they contain 3M surgical drapes that were previously recalled. The 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 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 recall of surgical equipment used in critical neurosurgery procedures. This qualifies as a risk-of-harm product where no illnesses or injuries have been reported, placing it at the maximum score of 3 per the rubric.
Plain-English summary
ROi CPS LLC is recalling 248 regard NEURO TRAY (NU00160R, Item Number 880158018) neurosurgery convenience kits. The recall is due to the inclusion of 3M surgical drapes that were the subject of a separate product recall.
The affected kits were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. The affected lot numbers are 91174 (expiration 10/18/2023), 91908 (expiration 2/2/2024), and 92566 (expiration 2/14/2024).
The recalled product
- Product
- regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 248
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 10194717113331
- Lot Numbers: 91174
- exp 10/18/2023
- 91908
- exp 2/2/2024
- 92566
- 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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