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U.S. Department of Health and Human Services

Class 2 Device Recall BARD Access Systems PowerPort ClearVUE Slim Implantable Port

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 Class 2 Device Recall BARD Access Systems PowerPort ClearVUE Slim Implantable Portsee related information
Date Initiated by FirmJanuary 15, 2020
Create DateMay 12, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1964-2020
Recall Event ID 85476
510(K)NumberK122899 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
ProductBARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.
Code Information Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.
FEI Number 2020394
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information ContactMr. Derrick Loud
480-638-2909
Manufacturer Reason
for Recall		The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
FDA Determined
Cause 2		Employee error
ActionThe recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.
Quantity in Commerce200 units
DistributionUS Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LJT
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