Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
FDA device recall Z-1477-2020 · posted 2020-02-28 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- 89 units
- Distribution
- US and UK
- Date initiated
- 2020-01-08
- Date posted
- 2020-02-28
- Date terminated
- 2023-01-13
- Location
- Miami Lakes, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA (K032737) | Cordis Europa, N.V. | 2003-10-02 |