Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Summary
The FDA issued a Class II for Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous by Resource Optimization & Innovation LLC. Reason: A kit component, the PDI Prevantics Swab, was recalled..
Details
Source
Device Recall
External ID
Z-0950-2022
Action Date
2022-04-27
Status
Terminated
Category
device
Product Description
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Lot/Code Info: 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
Quantity Affected: 3,570 kits
Reason for Recall
A kit component, the PDI Prevantics Swab, was recalled.
Distribution
US distribution to two consignees located in Missouri
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-28
Company
Saint Louis, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Resource Optimization & Innovation LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Resource Optimization & Innovation LLC have FDA actions?
This is the only FDA action we have on record for Resource Optimization & Innovation LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0950-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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