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U.S. Department of Health and Human Services

Class 2 Device Recall Hemodialysis System and Accessories

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 Class 2 Device Recall Hemodialysis System and Accessoriessee related information
Date Initiated by FirmJanuary 31, 2012
Date PostedFebruary 29, 2012
Recall Status1 Terminated 3 on September 12, 2012
Recall NumberZ-1126-2012
Recall Event ID 61184
510(K)NumberK910734 
Product Classification Needle, fistula - Product Code FIE
ProductMedisystems (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.
Code Information Lot Numbers: 110914F7, 110920F2
Recalling Firm/
Manufacturer		 Medisystems Corp
439 S Union St Fl 5th
Lawrence MA 01843-2837
For Additional Information Contact
978-687-4700
Manufacturer 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 2		Employee error
ActionMedisystems 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 Commerce20,750 units (83 cases)
DistributionUSA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FIE
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