CLASS II Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
regard Clinical Packaging Solutions recalled by ROi CPS
ROi CPS is recalling regard Clinical Packaging Solutions, distributed in Missouri. The recall was initiated on 4 Nov 2021 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-0411-2022
- FDA event ID
- 89078
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2021
- FDA classified
- 22 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 4 Nov 2021 | Recall initiated by company | |
| 22 Dec 2021 | Classified by FDA | +48 days |
| 29 Dec 2021 | 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
The kit contains a non-sterile needle.
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 Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Where it was distributed
Distribution was made to Missouri. There was no foreign/military/government distribution.
Questions about this recall
Why was it recalled?
The kit contains a non-sterile needle.
Which lots are affected?
Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
Where was it sold?
Distribution was made to Missouri. There was no foreign/military/government distribution.
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 |
| Device | CLASS II | Regard Kit containing the Microtek decanter recalled by ROi CPS | ROi CPS | Sterility | Nationwide |
| Device | CLASS I | regard Operative LAP recalled by ROi CPS | ROi CPS | Other | LA |
| Device | CLASS I | Regard Dressing change kit recalled by ROi CPS | ROi CPS | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Embosphere 500-700 micrometer Syringe Sterile Steam recalled | Merit Medical Systems | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care | Bayer Medical Care | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |