Recalls / —
—#179001
Product
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
- FDA product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K032737
- Affected lot / code info
- Lot 82155955, Use by date 2021-06-30
Why it was recalled
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 (FDA determination)
Pending
Action the firm took
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.
Recalling firm
- Firm
- Cordis Corporation
- Address
- 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802
Distribution
- Distribution pattern
- US and UK
Timeline
- Recall initiated
- 2020-01-08
- Posted by FDA
- 2020-02-28
- Terminated
- 2023-01-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #179001. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.