Date Initiated by Firm |
January 08, 2020 |
Date Posted |
February 28, 2020 |
Recall Status1 |
Terminated 3 on January 13, 2023 |
Recall Number |
Z-1477-2020 |
Recall Event ID |
84680 |
510(K)Number |
K032737
|
Product Classification |
Catheter, angioplasty, peripheral, transluminal - Product Code LIT
|
Product |
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S |
Code Information |
Lot 82155955, Use by date 2021-06-30 |
Recalling Firm/ Manufacturer |
Cordis Corporation 14201 NW 60th Ave Miami Lakes FL 33014-2802
|
For Additional Information Contact |
786-313-2000
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
89 units |
Distribution |
US and UK |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LIT and Original Applicant = CORDIS EUROPA N.V.
|