Edwards Lifesciences, LLC Recall 87993
Description: Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Edwards Lifesciences, LLC Recall 87993 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1961-2021 |
| Event ID | 87993 |
| Event Description | Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US |
| Product Type | Devices |
| 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 |
| Quantity | 290 units |
| Recall Reason | There is a potential that the pressure tubing may detach from the blood sampling system |
| Device Classification | 20210707 |
| Device Code Info | Lot # 63479666- Not Marketed within the US |
| Center Classification Date | 20210625 |
| Recall Initiation Date | 20210526 |
| Recalling Firm | Edwards Lifesciences, LLC |
| Initial Notification | Letter |
| Similar To |