Recall Z-0950-2022
Resource Optimization & Innovation LLC · initiated February 28, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Codes / lots: 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
Reason for recall
A kit component, the PDI Prevantics Swab, was recalled.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0950-2022
- Initiated
- February 28, 2022
- Terminated
- May 24, 2022
- Product code
- LRS – I.V. Start Kit
- Quantity
- 3,570 kits
- Distribution
- US distribution to two consignees located in Missouri
- Recalling firm
- Resource Optimization & Innovation LLC, Saint Louis, MO