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Class 2 Device Recall POWERPORT(R) ClearVUE(R) Slim with Smooth Septum, 8F ChronoFlex(TM), Polyurethane Catheter |
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| Date Initiated by Firm |
February 08, 2018 |
| Create Date |
May 09, 2018 |
| Recall Status1 |
Completed |
| Recall Number |
Z-1771-2018 |
| Recall Event ID |
79841 |
| 510(K)Number |
K122899
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| Product Classification |
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
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| Product |
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301 |
| Code Information |
Lot Number Unique Device Identifier (UDI) REAN0061 (01)00801741110818(17)170628(10)REAN0061 REAP0772 (01)00801741110818(17)170728(10)REAP0772 REAT1524 (01)00801741110818(17)171128(10)REAT1524 REAV1479 (01)00801741110818(17)171228(10)REAV1479 REAV1938 (01)00801741110818(17)171028(10)REAV1938 REAW0937 (01)00801741110818(17)171031(10)REAW0937 REAW1186 (01)00801741110818(17)171031(10)REAW1186 REAW1666 (01)00801741110818(17)171031(10)REAW1666 REAY0528 (01)00801741110818(17)171031(10)REAY0528 REAY0795 (01)00801741110818(17)171031(10)REAY0795 REAZ1529 (01)00801741110818(17)171231(10)REAZ1529 REBN0024 (01)00801741110818(17)171231(10)REBN0024 REBN1581 (01)00801741110818(17)180131(10)REBN1581 REBQ0210 (01)00801741110818(17)180131(10)REBQ0210 REBS1277 (01)00801741110818(17)181031(10)REBS1277 REBR1125 (01)00801741110818(17)181031(10)REBR1125 REBS1395 (01)00801741110818(17)181031(10)REBS1395 REBS2412 (01)00801741110818(17)181130(10)REBS2412 REBT1785 (01)00801741110818(17)181231(10)REBT1785 REBT2349 (01)00801741110818(17)181231(10)REBT2349 REBU0563 (01)00801741110818(17)181231(10)REBU0563 REBV0760 (01)00801741110818(17)190228(10)REBV0760 REBW1037 (01)00801741110818(17)190331(10)REBW1037 |
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
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Manufacturer Reason
for Recall |
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
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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 |
181 units |
| Distribution |
Nationwide |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = LJT and Original Applicant = C.R. BARD, INC.
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