Surgical Convenience Kit Recalled Due to Defective Component
ROi CPS LLC is recalling 345 units of regard Operative LAP surgical convenience kits distributed in Louisiana because they were manufactured with a component that was subsequently recalled by Nurse Assist.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates the most serious level of defect in a medical device, warranting Critical severity per the recall rubric.
Plain-English summary
The regard Operative LAP surgical convenience kit (Item Number 800943001) manufactured by ROi CPS LLC is being recalled. A total of 345 units were distributed in the United States, specifically to Louisiana. The recall was initiated because the kits were manufactured with a component that was subsequently recalled by Nurse Assist. The affected products are identified by UDI/DI 10194717111863 and Lot Numbers 94792, 95613, 96003, and 96845.
This is classified as a Class I recall by the Food and Drug Administration, the most serious classification level for medical devices. Individuals and healthcare facilities that have received these surgical convenience kits should verify their lot numbers against the list provided and discontinue use of any affected units. Contact ROi CPS LLC for information about product return or disposal.
The recalled product
- Product
- regard Operative LAP, Item Number 800943001; surgical convenience kit
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 345
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 10194717111863
- Lot Numbers: 94792
- 95613
- 96003
- 96845
Distribution
Distributed in 1 state:
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