Reported Apr 27, 2022 · Terminated
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Resource Optimization & Innovation LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Resource Optimization & Innovation LLC · 645 Maryville Centre Dr Ste 200 · Saint Louis, MO · 63141-5846
Is this the product you have?
- Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 303403REG20326053105252Manufacturer ; 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 303404REG20326053105269Manufacturer ; 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 57931Manufacturer Batch/Lot Number 273102, 275515, 276078, 276342, 277476, 279353, 281577, 282456, 283231, 283246, 284704, 289997, 288248 - Amount recalled
- 3,570 kits
Where it was sold
Why it was recalled
A kit component, the PDI Prevantics Swab, was recalled.
This product could cause temporary or reversible health problems — stop using it.
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