FDA Recall
Terminated
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Recall: Z-1477-2020
·
Initiated January 8, 2020
Recall
- Recall Number
- Z-1477-2020
- Event Number
- 84680
- Firm
- Cordis Corporation
- FEI Number
- 1016427
- Product Code
- LIT
- Status
- Terminated
- Root Cause
- Pending
- Initiated
- January 8, 2020
- Posted
- February 28, 2020
- Terminated
- January 13, 2023
- Address
- 14201 NW 60th Ave, Miami Lakes, FL, 33014-2802
Description
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
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.
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: [email protected].
Distribution
US and UK
Quantity
89 units