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Terminated

Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023

FDA Recall Z-0401-2011 · Posted 2010-11-17

Recalling FirmMillar Instruments, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2010-10-14
Date Terminated2011-02-15
Product Quantity12 Units

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.

Firm 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.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993694MIKRO-TIP ANGIOGRAPHIC CATHETERMillar Instruments, Inc. · 2000-03-01K952773MIKRO-TIP ANGIOGRAPHIC CATHETERMillar Instruments, Inc. · 1995-11-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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