CLASS II ONGOING Device recall · Reported 28 Aug 2024 · FDA Enforcement Report
Regard Kit containing the Microtek decanter recalled by ROi CPS
ROi CPS is recalling Regard Kit containing the Microtek decanter, distributed nationwide in the US. The recall was initiated on 17 Jun 2024 and the FDA has classified it as Class II.
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-2685-2024
- FDA event ID
- 94999
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2024
- FDA classified
- 16 Aug 2024
- Reported
- 28 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 17 Jun 2024 | Recall initiated by company | |
| 16 Aug 2024 | Classified by FDA | +60 days |
| 28 Aug 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Regard Kit containing the Microtek decanter
Where it was distributed
US Nationwide distribution in the state of MO.
Questions about this recall
Why was it recalled?
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Which lots are affected?
Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
Where was it sold?
US Nationwide distribution in the state of MO.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 |
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| Device | CLASS II | Regard CV PK recalled by ROi CPS | ROi CPS | Other | MO |
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