Recall Z-1004-2022 ยท OHM Cesarean Section Tray
ROi CPS LLC
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
| Date | Apr 26, 2022 (initiated Mar 18, 2022) |
| Status | Terminated |
| Reason | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm sent an email to the consignee on 3/18/2022 which said they have attached an Urgent Device Correction Notice for ROi CPS, LLC Convenience Kits that contain Regard branded IV Start Kits that were manufactured using PDI Prevantics products which were recalled by PDI. Attached to the email were the Urgent Device Correction notice dated 3/18/2022, a label template to be used to label the Regard IV start kits contained in the convenience kits, the original recall letter issued by PDI for their Prevantics products that were recalled, and a reply form. The Urgent Device Correct |
| Quantity | 290 convenience kits |
| Distribution | US Nationwide distribution in the state of Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.