EPIX THERAPEUTICS, INC Recall 87412
Description: EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
EPIX THERAPEUTICS, INC Recall 87412 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1320-2021 |
| Event ID | 87412 |
| Event Description | EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303 |
| Product Type | Devices |
| Distribution | Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada |
| Quantity | 18 units |
| Recall Reason | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli. |
| Device Classification | 20210407 |
| Device Code Info | All Lots |
| Center Classification Date | 20210329 |
| Recall Initiation Date | 20210222 |
| Recalling Firm | EPIX THERAPEUTICS, INC |
| Initial Notification | Letter |
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