FDA Medical Device Recalls (openFDA)
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 male luer-locking connector.
- Recall number
- Z-1126-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-01-31
- Posted
- 2012-02-29
- Terminated
- 2012-09-12
- 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.
- Lot, serial or model codes
- Lot Numbers: 110914F7, 110920F2
- 510(k) numbers
- ["K910734"]
- PMA numbers
- not on file
- Product code
- FIE
- Firm FEI
- not on file
- Firm city
- Lawrence
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28