—#163714

Product

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K122899
Affected lot / code info: Lot Number Unique Device Identifier (UDI) REAN0065 (01)00801741110788(17)170628(10)REAN0065 REAP0473 (01)00801741110788(17)170728(10)REAP0473 REAX1813 (01)00801741110788(17)180430(10)REAX1813 REAZ0278 (01)00801741110788(17)180331(10)REAZ0278 REBS1438 (01)00801741110788(17)180930(10)REBS1438 REBT1881 (01)00801741110788(17)180930(10)REBT1881

Why it was recalled

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

Root cause (FDA determination)

Error in labeling

Action the firm took

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."

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2018-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.