Recalls / —
—#192441
Product
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
- FDA product code
- LRS — I.V. Start Kit
- Device class
- Class 2
- Medical specialty
- General Hospital
- Affected 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
Why it was recalled
A kit component, the PDI Prevantics Swab, was recalled.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Resource Optimization & Innovation LLC
- Address
- 645 Maryville Centre Dr, Ste 200, Saint Louis, Missouri 63141-5846
Distribution
- Distribution pattern
- US distribution to two consignees located in Missouri
Timeline
- Recall initiated
- 2022-02-28
- Terminated
- 2022-05-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #192441. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.