Recall Z-2369-2020 ยท PEZ Central Venous Catheter Dressing Change Kit
Resource Optimization & Innovation LLC
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
| Date | May 4, 2020 |
| Status | Terminated |
| Reason | There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field. |
| Root cause | Under Investigation by firm |
| Action | The firm's supplier mailed an Urgent: Field Action Notification dated 04/21/2020 The notification informs the customers to remove the affected product from inventory and place it in quarantine immediately. The notification included a label template for printing the appropriate warning label. The customers will affix the warning label on all affected kits affected by the notification in inventory. The label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product inform |
| Quantity | 12,640 units |
| Distribution | US Nationwide distribution including in the states of MO, NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.