Z-1126-2012

Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector...

Name: Z-1126-2012 Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector...
Creator: Medisystems Corp
Published: 2012-01-31
License: https://open.fda.gov/license/

Medisystems Corp. / initiated 2012-01-31 / Terminated / root cause: manufacturing process

FDA source

Medisystems Corp began a recall of Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" Ref. Number: D9-2007MG. Medisystems AVF... on 2012-01-31. The reason FDA records is "Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1126-2012
Status: Terminated
Initiated: 2012-01-31
Posted: 2012-02-29
Terminated: 2012-09-12
Recalling firm: Medisystems Corp.
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.
Product code: FIE Needle, Fistula
Reason for recall: Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle
Root cause tag: manufacturing process
FDA 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 in commerce: 20,750 units (83 cases)
Distribution: USA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA.
Product codes and lots: Lot Numbers: 110914F7, 110920F2

Product code FIE

K910734Class IIMedisystems Hemodialysis Fistula SetMedisystems Corp. / cleared 1991-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)