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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Avanta Fluid Management Injection System

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  Class 2 Device Recall MEDRAD Avanta Fluid Management Injection System see related information
Date Initiated by Firm June 02, 2011
Date Posted July 22, 2011
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-2866-2011
Recall Event ID 59167
510(K)Number K050456  
Product Classification Injector and syringe, angiographic - Product Code DXT
Product MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL

Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures.
Code Information Catalog numbers: AVA 500 TABL, AVA 500 PEDL
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Julia Mitchell
724-940-6905
Manufacturer Reason
for Recall		 Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embo
FDA Determined
Cause 2		 Device Design
Action Medrad Inc., sent two types of "MEDICAL DEVICE FIELD CORRECTION" notifications on June 2, 2011 to all affected customers. 1. To those customers who Avanta Systems have already undergone market withdrawal and thus have been upgraded, the notification provided customer awareness that prior action should be considered a field correction. The letter stated that NO action is required since their system(s) has already been upgraded. If you have any questions, concerning these activities contact the Director of Quality Systems at (724) 940-6905. 2. To those customers whose Avanta Systems have not yet been upgraded through market withdrawal, the notification informed customers that the recalling firm is undertaking a Field Correction to upgrade their system(s). The letter included a step by step guide that will allow customers to verify that their system(s) has NOT been upgraded. Customers are instructed to complete and fax this form to MEDRAD at (412) 406-0941. If you have any questions, concerning these activities contact the Product Manager at (412) 767-2400, extension 8401.
Quantity in Commerce 842
Distribution Worldwide Distribution -- (USA) (nationwide) including the state of Puerto Ricoand the countries of: AE, AL, AT, BE, BG, BR, CA, CH, CO, CY, DE, DK, DO, ES, FI, FR, GB, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LY, MA, MT, MX, MY, NL, PA, PH, PK, PT, QA, RS, RU, SA, SE, SG, SI, TR, VI, and ZA.
Total Product Life Cycle TPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MEDRAD, INC.
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