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U.S. Department of Health and Human Services

Class 2 Device Recall POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 8F ChronoFlex(TM), Polyurethane Catheter

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  Class 2 Device Recall POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 8F ChronoFlex(TM), Polyurethane Catheter see related information
Date Initiated by Firm February 08, 2018
Create Date May 09, 2018
Recall Status1 Completed
Recall Number Z-1761-2018
Recall Event ID 79841
510(K)Number K063377  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Code Information Lot Number Unique Device Identifier (UDI) REAN0058 (01)00801741110740(17)170628(10)REAN0058 REAN0205 (01)00801741110740(17)170628(10)REAN0205 REAN1124 (01)00801741110740(17)170628(10)REAN1124 REAP0769 (01)00801741110740(17)170728(10)REAP0769 REAT1312 (01)00801741110740(17)171128(10)REAT1312 REBP1357 (01)00801741110740(17)180131(10)REBP1357 REBR0999 (01)00801741110740(17)180731(10)REBR0999 REBV0758 (01)00801741110740(17)180930(10)REBV0758 
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 2395 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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