Recall Z-0714-2013 ยท FIE Needle, Fistula
Medisystems a NX Stage Company
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
| Date | Jan 24, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| Reason | A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". |
| 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 | 26 casesx 250 needles (6500needles) |
| 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
| K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS Medisystems Corp., Jan 6, 2000 |