Nonsterile Components in Medical Convenience Kits Recalled
ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri because components that were supposed to be sterile were packaged as nonsterile.
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 medical device recall due to sterility failure. Components required to be sterile were found to be nonsterile, creating a risk-of-harm situation. Without reported injuries in the source and with theoretical hazard, it meets the criteria for High severity per the rubric.
Plain-English summary
ROi CPS LLC is recalling 86 nonsterile medical convenience kits distributed in Missouri. The affected products are Item #830099008 (CV01005H - CV Part 1 Bundle, Lot #92534, expires 11/13/2022) and Item #830019017 (CV00214Q - CV, Lot #92612, expires 8/31/2023).
Some components within these kits that were supposed to be sterile were packaged as nonsterile instead.
Customers and distributors who have received these kits should identify the affected products using the lot numbers and expiration dates provided. Contact ROi CPS LLC for instructions on how to handle or dispose of the recalled items.
The recalled product
- Product
- Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 86
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 (6)
- (1) Item #830099008 - Lot #92534
- exp. 11/13/2022
- UDI #10194717114895
- (2) Item #830019017 - Lot #92612
- exp. 8/31/2023
- UDI #10194717113249.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →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 · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighCV Minor Kit with Nonsterile Component Recalled for Contamination Risk
FDA (Devices) · 2022-07-06
- ModerateIV Start Kit Convenience Kits Recalled for Manufacturing Test Validation Issue
FDA (Devices) · 2022-05-04
- HighSterile surgical kit recalled due to light handle cover separation risk
FDA (Devices) · 2023-05-03
- HighSterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk
FDA (Devices) · 2023-05-03
- HighSurgical Convenience Kits Recalled for Separating Light Handle Covers
FDA (Devices) · 2023-05-03
- HighIV Start Kit Convenience Kits Recalled for Inadequate Test Method Validation
FDA (Devices) · 2022-05-04