CV Minor Kit with Nonsterile Component Recalled for Contamination Risk
ROi CPS LLC is recalling 180 CV Minor Kit units due to a nonsterile component accidentally packaged in the sterile kit, posing a contamination and infection risk.
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 an FDA Class II recall involving a sterile medical device with a nonsterile component, creating contamination and infection risks. No illnesses or injuries have been reported, placing it in the 'risk-of-harm' category per the rubric, which corresponds to a severity score of 3.
Plain-English summary
ROi CPS LLC is recalling 180 units of CV Minor Kit, Sterile (Item #800774001, CV00979A) distributed nationwide in the state of Florida. The affected product has Lot #91423 with an expiration date of 02/08/2024, identified by UDI (01)10194717101949(17)240208(10)91423.
The reason for the recall is that a nonsterile component was packaged in the sterile convenience kit. This compromises the sterile status of the product, which is essential for safe use in medical settings.
Healthcare facilities, clinics, and other affected parties should discontinue use of the recalled product immediately. Patients and healthcare providers should contact the manufacturer or the FDA for guidance regarding next steps.
The recalled product
- Product
- regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
- Manufacturer
- ROi CPS LLC
- Hazard
- contamination
- infection
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)
- Lot #91423
- Exp. 02/08/2024
- UDI (01)10194717101949(17)240208(10)91423.
Distribution
Distributed nationwide across the United States.
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