Regard LAMINECTOMY surgical kits recalled due to recalled 3M drapes
ROi CPS LLC is recalling Regard LAMINECTOMY surgical convenience kits because they contain 3M surgical drapes that were subsequently recalled.
What this means for you
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 a Class II recall for surgical convenience kits containing components that were recalled by their manufacturer. As risk-of-harm medical devices with no reported illnesses or injuries to date, the recall warrants a High severity rating per FDA severity criteria.
Plain-English summary
ROi CPS LLC is recalling Regard LAMINECTOMY surgical convenience kits due to the inclusion of 3M surgical drapes that were subsequently recalled. The kits were distributed to facilities in Louisiana, Missouri, North Carolina, and Florida. This recall affects 42 kits (UDI/DI 10194717110392, Lot Number 91590, expiration date 01/09/2024).
Healthcare facilities that received these kits should cease use immediately and contact ROi CPS LLC for further instructions regarding return or destruction of the product. Patients who may have concerns about surgical procedures performed using drapes from these kits should contact their healthcare provider.
The recalled product
- Product
- regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 42
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 10194717110392
- Lot Number 91590
- exp 01/09/2024
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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