FDA Device recall Z-0950-2022
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
- FDA Device
- Class II
- terminated
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site by Resource Optimization And Innovation, citing A kit component, the PDI Prevantics Swab, was recalled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0950-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-28 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Resource Optimization And Innovation |
| Distribution | MO |
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.
Identifiers
| code_info | a. Manufacturer Item 303403REG; UDI: 20326053105252 Batch/Lot Number 272394, 272723, 273243, 274119, 274222, 275120, 2…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0950-2022%22
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