Recall Z-0756-2021 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Lidco Ltd
CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
| Date | Nov 19, 2020 |
| Status | Terminated |
| Reason | The expiration date on labeling is incorrect. |
| Root cause | Labeling mix-ups |
| Action | The recalling firm contacted consignees via email to notify of the recall. Customers are asked to return impacted product to the recalling firm. |
| Quantity | 40 packs (5 each per pack) |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of IL and the country of Kuwait. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163334 | LiDCOunity v2 Hemodynamic Monitor Lidco, Ltd., Jun 5, 2017 |