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.
This recall is currently active, issued January 15, 2020. It was issued by Bard Peripheral Vascular Inc.
- Company
- Bard Peripheral Vascular Inc
- Recall Initiated
- January 15, 2020
- Recall Number
- Z-1964-2020
- Quantity
- 200 units
- Firm Location
- Tempe, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Distribution
US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
Lot / Code Info
Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.
Root Cause
Employee error
Action Taken
The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.
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