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U.S. Department of Health and Human Services

Class 2 Device Recall Avanta Fluid Management Injection System

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  Class 2 Device Recall Avanta Fluid Management Injection System see related information
Date Initiated by Firm January 06, 2010
Date Posted March 23, 2010
Recall Status1 Terminated 3 on April 08, 2010
Recall Number Z-1199-2010
Recall Event ID 54453
510(K)Number K050456  
Product Classification Angiographic Injector and Syringe - Product Code DXT
Product Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
Code Information Lot numbers 820007 and 820008
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Deb Easler
412-767-2400 Ext. 8401
Manufacturer Reason
for Recall		 The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued an Urgent Medical Device Recall letter dated 1/6/10 to all customers that received the affected lots. The customers were instructed to determine whether or not they had the affected product lots. Customers are to discontinue use and contact MEDRAD Customer Support or their MIP Rep to make arrangements for return of the recalled product. Any affected product returned will be replaced at no charge to the customer. Customers are also to complete and sign the attached form and fax it back to the firm. Questions concerning this recall are to be directed to Deb Easler, Product Manager, at 412-767-2400.
Quantity in Commerce 2625 pieces
Distribution Worldwide Distribution -- USA, including stated of AL, AZ, CA, DC, FL, GA, IL, KS, MD, MO, NM, NY, OH,OK, PA, TN, TX, and WI. and countries of Belgium, Germany, and Italy.
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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