Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis
FDA device recall Z-0234-04 · posted 2003-12-17 · Terminated
Recall details
- Recalling firm
- Kendall Healthcare Products Co
- Reason for recall
- Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm
- Action taken
- Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MPB
- Quantity affected
- 10
- Distribution
- IL, MA, OH, TN, TX, VA
- Date initiated
- 2003-12-02
- Date posted
- 2003-12-17
- Date terminated
- 2012-05-15
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAHURKAR OPLUS CATHETER, MODEL 13.5 FR (K030209) | The Kendall Company | 2003-05-13 |