—#181044

Product

BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.

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 #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.

Why it was recalled

The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.

Root cause (FDA determination)

Employee error

Action the firm took

The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.

Timeline

Recall initiated: 2020-01-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181044. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.