Device product
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Z-0950-2022
Product summary
- Event
- Event 89793
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,570 kits
- Official record key
device-enforcement:Z-0950-2022
Official wording
Reason: A kit component, the PDI Prevantics Swab, was recalled.
Code information: 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
Distribution pattern: US distribution to two consignees located in Missouri
Derived failure modes
-
Unknown
A kit component, the PDI Prevantics Swab, was recalled.