Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Hous
FDA device recall Z-0401-2011 · posted 2010-11-17 · Terminated
Recall details
- Recalling firm
- Millar Instruments, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 12 Units
- Distribution
- Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.
- Date initiated
- 2010-10-14
- Date posted
- 2010-11-17
- Date terminated
- 2011-02-15
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MIKRO-TIP ANGIOGRAPHIC CATHETER (K993694) | Millar Instruments, Inc. | 2000-03-01 |
| MIKRO-TIP ANGIOGRAPHIC CATHETER (K952773) | Millar Instruments, Inc. | 1995-11-07 |