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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis POWERFLEX P3, PTA Dilation Catheter

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 Class 2 Device Recall Cordis POWERFLEX P3, PTA Dilation Cathetersee related information
Date Initiated by FirmJanuary 08, 2020
Date PostedFebruary 28, 2020
Recall Status1 Terminated 3 on January 13, 2023
Recall NumberZ-1477-2020
Recall Event ID 84680
510(K)NumberK032737 
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
ProductCordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Code Information Lot 82155955, Use by date 2021-06-30
FEI Number 1016427
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
ActionThe 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 Commerce89 units
DistributionUS and UK
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = LIT
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