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U.S. Department of Health and Human Services

Class 2 Device Recall POWERPORT(R) ClearVUE(R) Slim with Smooth Septum, 6F ChronoFlex(TM) Silk, Polyurethane Catheter

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 Class 2 Device Recall POWERPORT(R) ClearVUE(R) Slim with Smooth Septum, 6F ChronoFlex(TM) Silk, Polyurethane Cathetersee related information
Date Initiated by FirmFebruary 08, 2018
Create DateMay 09, 2018
Recall Status1 Completed
Recall NumberZ-1762-2018
Recall Event ID 79841
510(K)NumberK122899 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
ProductPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Code Information Lot Number Unique Device Identifier (UDI) REAN0062 (01)00801741110764(17)170628(10)REAN0062 REAP0628 (01)00801741110764(17)170828(10)REAP0628 REAU0228 (01)00801741110764(17)171228(10)REAU0228 REAW1710 (01)00801741110764(17)180331(10)REAW1710 REAY0677 (01)00801741110764(17)180531(10)REAY0677 REAY2493 (01)00801741110764(17)180331(10)REAY2493 REBQ0468 (01)00801741110764(17)180331(10)REBQ0468 REBS1274 (01)00801741110764(17)180930(10)REBS1274 REBS1900 (01)00801741110764(17)180930(10)REBS1900 REBT2147 (01)00801741110764(17)181130(10)REBT2147 REBV1310 (01)00801741110764(17)181231(10)REBV1310 REBW0863 (01)00801741110764(17)181231(10)REBW0863 REBX2269 (01)00801741110764(17)190430(10)REBX2269 
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
ActionThe 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 Commerce1551 units
DistributionNationwide
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.
510(K) Database510(K)s with Product Code = LJT
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