Regard IV Start Kit for preparing and/or dressing a… recallZ-0950-2022 · Resource Optimization & Innovation LLC · initiated Feb 28, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Resource Optimization & Innovation LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A kit component, the PDI Prevantics Swab, was recalled.
FDA root cause category: Process control
What the company is doing
ROI issued correction notices on 02/28/2022 and 03/07/2022 to the initial consignees who had been shipped the affected Regard brand IV Start Kits containing the affected PDI Prevantics products. There will be no product recovered due to the notice received from Owens & Minor instructing that the affected kits be labeled with an label instructing the user not to use the Prevantics products.
Recall details
- Recall number
- Z-0950-2022
- Status
- Terminated
- Initiated by the company
- Feb 28, 2022
- Recalling firm
- Resource Optimization & Innovation LLC
- Quantity
- 3,570 kits
- Product code
- LRS
- Distribution
- US distribution to two consignees located in Missouri
Product description
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ 303403Resource Optimization & Innovation, L.L.C. · I.V. Start Kit1 recall0 reports
- Regard™ 303404Resource Optimization & Innovation, L.L.C. · I.V. Start Kit1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page