Recall Z-0715-2013 ยท FIE Needle, Fistula
Medisystems a NX Stage Company
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
| Date | Jan 24, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge |
| Root cause | Labeling mix-ups |
| Action | Medisystems sent a notification letter dated December 20, 2012 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to immediately open and inspect inventory for the affected products. Results of the inspection are to be provided to Medisystems and the product is to be returned to Medisystems. For questions call (978) 332-5973. |
| Quantity | 16 cases (15 cs x 250 ea) 4,000 needles |
| Distribution | US Nationwide Distribution in the states of NY, PA and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET Medisystems Corp., Jun 20, 1991 |