Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
This recall has been terminated (originally issued February 28, 2020).
- Company
- Cordis Corporation
- Recall Initiated
- January 8, 2020
- Posted
- February 28, 2020
- Terminated
- January 13, 2023
- Recall Number
- Z-1477-2020
- Quantity
- 89 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
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.
Distribution
US and UK
Lot / Code Info
Lot 82155955, Use by date 2021-06-30
Root Cause
Pending
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.