Recall archive / FDA device enforcement
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site — FDA record Z-0950-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 28, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
- Reason
- A kit component, the PDI Prevantics Swab, was recalled.
- Classification
- Class II
- Recalling firm
- Resource Optimization & Innovation LLC
- Quantity
- 3,570 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0950-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to two consignees located in Missouri
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 27, 2022
- Recall initiation date
- Feb 28, 2022
- Center classification date
- Apr 18, 2022
- Termination date
- May 24, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.