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U.S. Department of Health and Human Services

Class 2 Device Recall Regard IV Start Kit

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  Class 2 Device Recall Regard IV Start Kit see related information
Date Initiated by Firm February 28, 2022
Create Date April 18, 2022
Recall Status1 Terminated 3 on May 24, 2022
Recall Number Z-0950-2022
Recall Event ID 89793
Product Classification I.V. start kit - Product Code LRS
Product Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
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
Recalling Firm/
Manufacturer		 Resource Optimization & Innovation LLC
645 Maryville Centre Dr Ste 200
Saint Louis MO 63141-5846
For Additional Information Contact Cheyenne L. Stewart
417-647-3205
Manufacturer Reason
for Recall		 A kit component, the PDI Prevantics Swab, was recalled.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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