Recall Z-1126-2012 ยท FIE Needle, Fistula
Medisystems Corp
Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" Ref. Number: D9-2007MG. 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
| Date | Feb 29, 2012 (initiated Jan 31, 2012) |
| Status | Terminated |
| Reason | Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle |
| Root cause | Employee error |
| Action | Medisystems Corporation issued notice of recall to distributors on January 31, 2012. Distributors to notify affected end users by letter. Each letter was accompanied by a response form and instructions on how to return the response form. End users were given the option of returning involved product for credit or replacement. Contact Medisystems Quality Assurance Manager at (978) 332-5973 for information. |
| Quantity | 20,750 units (83 cases) |
| Distribution | USA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET Medisystems Corp., Jun 20, 1991 |