Recall Z-0401-2011
Millar Instruments, Inc · initiated October 14, 2010
Product
Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023
Codes / 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.
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.
FDA-determined cause: Packaging
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.
Details
- Recall number
- Z-0401-2011
- Initiated
- October 14, 2010
- Posted by FDA
- November 17, 2010
- Terminated
- February 15, 2011
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Quantity
- 12 Units
- Distribution
- Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.
- Recalling firm
- Millar Instruments, Inc, Houston, TX