CLASS I Device recall · Reported 10 Jan 2024 · FDA Enforcement Report
Regard Dressing change kit recalled by ROi CPS
ROi CPS is recalling Regard Dressing change kit, distributed nationwide in the US. The recall was initiated on 20 Nov 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0596-2024
- FDA event ID
- 93525
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Nov 2023
- FDA classified
- 3 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Nov 2023 | Recall initiated by company | |
| 3 Jan 2024 | Classified by FDA | +44 days |
| 10 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Product as listed by the FDA
Regard Dressing change kit, Item Number 800026006
Where it was distributed
US Nationwide distribution in the state of Louisiana.
Questions about this recall
Why was it recalled?
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Which lots are affected?
UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Where was it sold?
US Nationwide distribution in the state of Louisiana.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ROi CPS
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled | ROi CPS | Potency & Assay | MO |
| Device | CLASS II | regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled | ROi CPS | Packaging Defects | Nationwide |
| Device | CLASS II | Regard Kit containing the Microtek decanter recalled by ROi CPS | ROi CPS | Sterility | Nationwide |
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| Device | CLASS II | Regard CV PK recalled by ROi CPS | ROi CPS | Other | MO |
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