Z-1199-2010

Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check...

Name: Z-1199-2010 Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check...
Creator: Medrad Inc
Published: 2010-01-06
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2010-01-06 / Terminated / root cause: manufacturing process

FDA source

Medrad Inc began a recall of Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number... on 2010-01-06. The reason FDA records is "The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1199-2010
Status: Terminated
Initiated: 2010-01-06
Posted: 2010-03-23
Terminated: 2010-04-08
Recalling firm: Medrad, Inc.
Product: Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot numbers 820007 and 820008

Product code DXT

K050456Class IIMedrad Avanta Fluid Management Injection SystemMedrad, Inc. / cleared 2005-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)