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Recall Observatory FDA recall evidence

Device product

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

Z-0950-2022

February 28, 2022

Class II

Product summary

Firm
Resource Optimization & Innovation LLC
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

    reason.no_named_rule · v1.0.0

    A kit component, the PDI Prevantics Swab, was recalled.