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 / numberBarcodesProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 24, 2022 · Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.