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.
FDA Recall Z-1126-2012 · Posted 2012-02-29
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Recalling FirmMedisystems Corp
Recall StatusTerminated
Product CodeFIE
Date Initiated2012-01-31
Date Terminated2012-09-12
Product Quantity20,750 units (83 cases)
Reason for Recall
Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle
Firm 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.
Root Cause
Employee error
Distribution Pattern
USA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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