FDA Medical Device Recalls (openFDA)
Millar Instruments, Inc: Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023
- Recall number
- Z-0401-2011
- Recalling firm
- Millar Instruments, Inc
- Product
- Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023
- Status
- Terminated
- Initiated
- 2010-10-14
- Posted
- 2010-11-17
- Terminated
- 2011-02-15
- Reason
- 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
- 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
- 12 Units
- Distribution
- Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K952773","K993694"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1625382
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28