Regard IV Start Kit for preparing and/or dressing a recall
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
Why was Regard IV Start Kit for preparing and/or dressing a recalled?
A kit component, the PDI Prevantics Swab, was recalled.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
- Recalling firm
- Resource Optimization & Innovation LLC
- Quantity
- 3,570 kits
- Distribution
- US distribution to two consignees located in Missouri
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)