Recall Z-0161-2016 ยท LLB System, Blood, Extracorporeal And Accessories
Nipro Medical Corporation
Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
| Date | Oct 23, 2015 (initiated Aug 13, 2015) |
| Status | Terminated |
| Reason | Some 1 1/4" needles were packaged and labeled in the 1" blister package. |
| Root cause | Mixed-up of materials/components |
| Action | Customers were issued a RMA 60001203 on August 18, 2015. |
| Quantity | 50,000 pieces |
| Distribution | Indiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071145 | NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE Nipro Medical Corporation, Sep 7, 2007 |