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.
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: 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
- Affected units
- 180
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
Related recalls
Same manufacturer · ROi CPS LLC
See all →- SevereNewborn Resuscitator Kit Recalled for Inline Spring Defect
FDA (Devices) · 2025-02-12
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighRegard Kit Decanters Recalled for Defective Sterile Packaging
FDA (Devices) · 2024-08-28
- CriticalSurgical Convenience Kit Recalled Due to Defective Component
FDA (Devices) · 2024-01-24
- SevereRegard Dressing Change Kit Recalled Due to Defective Irrigation Solution
FDA (Devices) · 2024-01-10
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighNonsterile convenience kit recall due to sterile component mislabeling
FDA (Devices) · 2022-07-27
- HighNonsterile Components in Medical Convenience Kits Recalled
FDA (Devices) · 2022-07-27
- HighSterile surgical kit recalled due to light handle cover separation risk
FDA (Devices) · 2023-05-03
- HighSterile surgical C-section kit light handle covers recalled for separation risk
FDA (Devices) · 2023-05-03
- HighSterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk
FDA (Devices) · 2023-05-03
- ModerateIV Start Kit Convenience Kits Recalled for Manufacturing Test Validation Issue
FDA (Devices) · 2022-05-04