FDA-Device2020-05-20Class II
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.
Bard Peripheral Vascular Inc
Hazard
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Sold states
US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
Affected count
200 units
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1964-2020Don't want to check this manually?
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