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U.S. Department of Health and Human Services

Class 2 Device Recall POWERPORT(R) ClearVUE(R) Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Ope

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  Class 2 Device Recall POWERPORT(R) ClearVUE(R) Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Ope see related information
Date Initiated by Firm February 08, 2018
Create Date May 09, 2018
Recall Status1 Completed
Recall Number Z-1773-2018
Recall Event ID 79841
510(K)Number K122899  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
Code Information Lot Number Unique Device Identifier (UDI) REAN0056 (01)00801741110894(17)170628(10)REAN0056 REAN0203 (01)00801741110894(17)170628(10)REAN0203 REAP0773 (01)00801741110894(17)170728(10)REAP0773 REBN0925 (01)00801741110894(17)180131(10)REBN0925 
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
Manufacturer Reason
for Recall		 The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
FDA Determined
Cause 2		 Error in labeling
Action The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Quantity in Commerce 10 units
Distribution Nationwide
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = C.R. BARD, INC.
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