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Recall Observatory FDA recall evidence

Device 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.

Z-1964-2020

January 15, 2020

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 85476
Status
Ongoing
Classification
Class II
Quantity
200 units
Official record key
device-enforcement:Z-1964-2020

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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