CLASS II Device recall · Reported 30 Nov 2022 · FDA Enforcement Report
regard Pediatric Urology, GS00467J recalled by ROi CPS
ROi CPS is recalling regard Pediatric Urology, GS00467J, distributed in Florida, Louisiana, Missouri, North Carolina. The recall was initiated on 20 Oct 2022 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-0317-2023
- FDA event ID
- 91069
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2022
- FDA classified
- 23 Nov 2022
- Reported
- 30 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2022 | Recall initiated by company | |
| 23 Nov 2022 | Classified by FDA | +34 days |
| 30 Nov 2022 | 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
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Product as listed by the FDA
regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit
Where it was distributed
LA, MO, NC, FL
Questions about this recall
Why was it recalled?
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Which lots are affected?
UDI/DI 10194717104742, Lot Numbers: 91265, exp 1/20/2024; 92541, exp 5/17/2024
Where was it sold?
LA, MO, NC, FL
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
39 other products · FDA event 91069This product is part of a recall event; the main page for the event is regard Davinci Pack, GS00137W recalled by ROi CPS.
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 | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |