Z-0950-2022Class II

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

Name: Z-0950-2022 Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Creator: Resource Optimization & Innovation LLC
Published: 2022-02-28
License: https://open.fda.gov/license/

Resource Optimization & Innovation, LLC / initiated 2022-02-28 / Terminated / root cause: manufacturing process

FDA source

Resource Optimization & Innovation LLC began a recall of Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site on 2022-02-28. FDA classified it as Class II and gives the reason as "A kit component, the PDI Prevantics Swab, was recalled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0950-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-28
Posted: 2022-04-18
Terminated: 2022-05-24
Recalling firm: Resource Optimization & Innovation, LLC
Product: Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Product code: LRS I.V. Start Kit
Reason for recall: A kit component, the PDI Prevantics Swab, was recalled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 3,570 kits
Distribution: US distribution to two consignees located in Missouri
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0950-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0950-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-27	2022-04-18

Product code LRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)