Recall Z-0599-2016 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Nipro Medical Corporation
NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.
| Date | Apr 1, 2014 |
| Status | Terminated |
| Reason | Device has the potential to have torn wings. |
| Root cause | Process control |
| Action | The only one Distributor was notified (2014) by e-mail by the firm of the quality deficiency before the product arrived at their facility. It was immediately returned to Nipro Medical when it arrived. |
| Quantity | 160,000 pieces. |
| Distribution | US distribution including TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE Nipro Medical Corp., Nov 14, 2003 |