Recall Z-0408-03 ยท FIE Needle, Fistula
Nipro Corp
The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.
| Date | May 21, 2003 (initiated Nov 8, 2002) |
| Status | Terminated |
| Reason | Air or fluid leakage at the hub/needle junction. |
| Root cause | Other |
| Action | The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future. |
| Quantity | 6,984,000 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002813 | NIPRO SAFETOUCH SAFETY FISTULA NEEDLE Nipro Medical Corp., Nov 21, 2000 |