Recall Z-1126-2012
Medisystems Corp · initiated January 31, 2012
Product
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 male luer-locking connector.
Codes / lots: Lot Numbers: 110914F7, 110920F2
Reason for recall
Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-1126-2012
- Initiated
- January 31, 2012
- Posted by FDA
- February 29, 2012
- Terminated
- September 12, 2012
- Product code
- FIE – Needle, Fistula
- Quantity
- 20,750 units (83 cases)
- Distribution
- USA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA.
- Recalling firm
- Medisystems Corp, Lawrence, MA