Surgical Urology Kits Recalled Due to Defective 3M Drapes
ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida. The kits contained 3M surgical drapes that were subject to a separate recall.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is precautionary in nature, involving removal of kits that contained already-recalled components. Per the rubric, voluntary precautionary recalls are classified as Moderate severity.
Plain-English summary
ROi CPS LLC is recalling 166 Regard Pediatric Urology surgical convenience kits (Model GS00467J, Item Number 880306010, UDI/DI 10194717104742). The kits were distributed to Louisiana, Missouri, North Carolina, and Florida. Two lot numbers are affected: Lot 91265 (expiration date 1/20/2024) and Lot 92541 (expiration date 5/17/2024).
The recalled kits contain 3M surgical drapes that were subject to a separate recall. ROi CPS LLC is recalling these kits in response.
Healthcare facilities that received kits with the affected lot numbers should cease use and contact ROi CPS LLC for return instructions. Consult the FDA recall notice for additional information.
The recalled product
- Product
- regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 166
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 10194717104742
- Lot Numbers: 91265
- exp 1/20/2024
- 92541
- exp 5/17/2024
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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