CLASS II Device recall · Reported 27 Apr 2022 · FDA Enforcement Report
Regard IV Start Kit for preparing and/or dressing recalled
Resource Optimization & Innovation is recalling Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access, distributed in Missouri. The recall was initiated on 28 Feb 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-0950-2022
- FDA event ID
- 89793
- Recalling firm
- Resource Optimization & Innovation, Saint Louis, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2022
- FDA classified
- 18 Apr 2022
- Reported
- 27 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Feb 2022 | Recall initiated by company | |
| 18 Apr 2022 | Classified by FDA | +49 days |
| 27 Apr 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A kit component, the PDI Prevantics Swab, was recalled.
Product as listed by the FDA
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Where it was distributed
US distribution to two consignees located in Missouri
Questions about this recall
Why was it recalled?
A kit component, the PDI Prevantics Swab, was recalled.
Which lots are affected?
a. Manufacturer Item 303403REG; UDI: 20326053105252 Batch/Lot Number 272394, 272723, 273243, 274119, 274222, 275120, 275700, 276890, 277198, 277650, 278195, 278702, 278984, 279240, 279592, 281107, 282148, 282546, 283355, 283758, 283985, 284757, 285260, 286471, 287025, 287757, 287995, 288331, 288535, 289809, 290876, 291283, 292384 b. Manufacturer Item 303404REG; UDI: 20326053105269 Batch/Lot Number 272920, 273244, 273589, 273982, 275005, 275462, 276185, 276898, 277665, 279246, 279597, 283768, 284492, 285144, 285594, 286503, 287537, 288105, 281116, 281378, 281951, 282860, 288553, 288990, 289829, 290601 c. Manufacturer Item 57931 Batch/Lot Number 273102, 275515, 276078, 276342, 277476, 279353, 281577, 282456, 283231, 283246, 284704, 289997, 288248
Where was it sold?
US distribution to two consignees located in Missouri
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.
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