Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Mode
FDA device recall Z-1725-2011 · posted 2011-03-24 · Terminated
Recall details
- Recalling firm
- Millar Instruments, Inc
- Reason for recall
- Possibility of epoxy debris particles inside the catheter lumen.
- Action taken
- The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed. If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 1080 units
- Distribution
- MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway.
- Date initiated
- 2011-03-08
- Date posted
- 2011-03-24
- Date terminated
- 2011-06-27
- 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 |