Z-0401-2011

Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf...

Name: Z-0401-2011 Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf...
Creator: Millar Instruments, Inc
Published: 2010-10-14
License: https://open.fda.gov/license/

Millar LLC. / initiated 2010-10-14 / Terminated / root cause: packaging

FDA source

Millar Instruments, Inc began a recall of Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023 on 2010-10-14. The reason FDA records is "The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted...". 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-0401-2011
Status: Terminated
Initiated: 2010-10-14
Posted: 2010-11-17
Terminated: 2011-02-15
Recalling firm: Millar LLC.
Product: Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing.
Root cause tag: packaging
FDA root cause: Packaging
Action: Millar issued a Recall Report letter on October 14, 2010 to consignees identifying the affected product, sterility issue, and actions to be taken. Customers are to return all unused catheters to Millar for replacement. Customers can contact Millar about this recall at 832-667-7131.
Quantity in commerce: 12 Units
Distribution: Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.
Product codes and lots: Catalog-Models: SPC-454D, SPC-454E, SPC-454F, SPC-464D. Product Code/Part No.: 800-4219-1, 800-4219-2, 800-4219-3, 802-1029X. Lot No.: L057674, L064963, L057687, L062222, L061409, L057687, L065039, L058763. S/N: 407126, 407128, 493801, 391962, 466255, 466256, 435426, 391965, 391968, 493756, 425284, 425285.

Product code DQO

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)