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Class 2 Device Recall BARD Access Systems PowerPort ClearVUE Slim Implantable Port |
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Date Initiated by Firm |
January 15, 2020 |
Create Date |
May 12, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1964-2020 |
Recall Event ID |
85476 |
510(K)Number |
K122899
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Product Classification |
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
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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. |
Code Information |
Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530. |
Recalling Firm/ Manufacturer |
Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 Tempe AZ 85281-2438
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For Additional Information Contact |
Mr. Derrick Loud 480-638-2909
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Manufacturer Reason for Recall |
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
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FDA Determined Cause 2 |
Employee error |
Action |
The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned. |
Quantity in Commerce |
200 units |
Distribution |
US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = LJT and Original Applicant = C.R. BARD, INC.
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