Recall Z-1962-2021 ยท DXO Transducer, Pressure, Catheter Tip
Edwards Lifesciences, LLC
Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
| Date | May 26, 2021 |
| Status | Terminated |
| Reason | There is a potential that the pressure tubing may detach from the blood sampling system |
| Root cause | Under Investigation by firm |
| Action | On May 26, 2021 Edwards Lifesciences issued a "Urgent Medical Device Recall" Notification via FedEx to all affected consignees. In addition to informing consignees about the recalled product, the firm asked consignees to take the following actions: 1. Action to be taken by user: We request that you return all unused product in your inventory with the model and lot numbered reference above. For product that has been used and will be returned, please contact Customer Service at 1-800-424-3278 to request a biokit. Please review your inventory and quarantine any affected product until prepared f |
| Quantity | 2,000 units |
| Distribution | US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy |
| FDA record | Open on fda.gov |