Surgical Convenience Kits with Recalled 3M Surgical Drapes
ROi CPS LLC is recalling 21 surgical convenience kits distributed to Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that were subsequently recalled.
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 a medical device (surgical drape) inherently used in surgical procedures, qualifying as a risk-of-harm product. No reported illnesses or injuries are documented, and the specific defect is not detailed in this notice.
Plain-English summary
ROi CPS LLC is recalling surgical convenience kits (model NU00974F, Item Number 800769006) that were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. A total of 21 kits were distributed. The affected lot is 91584 with an expiration date of September 2023.
The kits were recalled because they contain 3M surgical drapes, which were subsequently recalled. The specific reason for the 3M surgical drape recall is not provided in this notice.
Healthcare facilities that received these kits should consult the original 3M surgical drape recall information for details about the defect and appropriate actions regarding the affected kits.
The recalled product
- Product
- regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 21
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 10194717114062
- Lot Numbers: 91584
- exp 9/23/2023
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.
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