Regard IV Start Kit (Resource Optimization) – Swab Recall (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Brand
Resource Optimization & Innovation LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Resource Optimization & Innovation LLC is recalling Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site due to A kit component, the PDI Prevantics Swab, was recalled.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A kit component, the PDI Prevantics Swab, was recalled.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MO
Page updated: Jan 10, 2026