Z-0292-2008

Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA...

Name: Z-0292-2008 Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA...
Creator: Medrad Inc
Published: 2007-10-25
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2007-10-25 / Terminated / root cause: packaging

FDA source

Medrad Inc began a recall of Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid... on 2007-10-25. The reason FDA records is "Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0292-2008
Status: Terminated
Initiated: 2007-10-25
Posted: 2007-12-11
Terminated: 2008-04-22
Recalling firm: Medrad, Inc.
Product: Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The recalling firm issued an Urgent Medical Device Field Correction Letter dated 10/25/07 via Federal Express to their customers informing them of the problem. Customers can either return the product or consistent with the indicated use and established pratice of sheathing, utilize sterile sheaths with the hand controllers for up to five patients. Each letter is being accompanied by a box of 25 sheaths.
Quantity in commerce: 25, 977 units
Distribution: Worldwide-USA and countries of Germany, Israel, Finalnd, Italy, Netherland, Austria, France, Japan, Denmark, Ireland, South Africia, Australia, Saudi Arabia, Singapore, Canada, New Zealand, Spain, Sweden, Portugal, Korea, Great Britain, Turkey and The United Arab Emerites.
Product codes and lots: Catalog Number : AVA500HC. Lot Numbers: 0906AACL01, 0906AACL02, 1006AACL01, 1006AACL02, 1006AACL03, 1106AACL01, 1106AACL03, 1106AACL04, 1106AACL05, 1206AACL01, 1206AACL02, 1206AACL03, 0107AACL01, 0107AACL02, 0107AACL03, 0107AACL04, 0107AACL05, 0107AACL06, 0207AACL01, 0307AACL01, 0307AACL02, 0307AACL03, 0407AACL01, 0407AACL02, 0507AACL01, 0507AACL02, 0607AACL01, 0607AACL02, 0607AACL03, and 0707AACL01.

Product code DXT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)