Recall Z-0950-2022 ยท LRS I.V. Start Kit
Resource Optimization & Innovation LLC
Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
| Date | Feb 28, 2022 |
| Status | Terminated |
| Reason | A kit component, the PDI Prevantics Swab, was recalled. |
| 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 | 3,570 kits |
| Distribution | US distribution to two consignees located in Missouri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.