Recall Z-1477-2020 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Cordis Corporation
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
| Date | Feb 28, 2020 (initiated Jan 8, 2020) |
| Status | Terminated |
| Reason | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area. |
| Root cause | Pending |
| Action | The firm initiated the recall by letter on 01/08/2020. The letter explained the issue and the hazard, and requested the consignee check their inventory for the product, isolate any affected units and return the acknowledgement form. The firm is seeking the return of the affected units. The firm directed the consignee to share the notice with any entity to whom the product was further distributed. Questions regarding the recall should be sent to: GMB-FieldCorrectiveAction@cardinalhealth.com. |
| Quantity | 89 units |
| Distribution | US and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032737 | CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA Cordis Europa, N.V., Oct 2, 2003 |