Recall Z-0233-04 ยท MPB Catheter, Hemodialysis, Non-Implanted
Kendall Healthcare Products Co
Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192
| Date | Dec 17, 2003 (initiated Dec 2, 2003) |
| Status | Terminated |
| Reason | Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm |
| Root cause | Other |
| Action | Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003. |
| Quantity | 45 units |
| Distribution | IL, MA, OH, TN, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR The Kendall Company, May 13, 2003 |