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U.S. Department of Health and Human Services

Class 2 Device Recall Medisytems

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 Class 2 Recall
Medisytems
see related information
Date Posted January 24, 2013
Recall Status1 Terminated on October 10, 2013
Recall Number Z-0715-2013
Recall Event ID 63959
Premarket Notification
510(K) Number
K910734 
Product Classification Needle, Fistula - Product Code FIE
Product Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: 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: Number: 110914F8
Recalling Firm/
Manufacturer
Medisystems a NX Stage Company
350 Merrimack St
Lawrence, Massachusetts 01843-1748
Manufacturer Reason
for Recall
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Medisystems sent a notification letter dated December 20, 2012 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to immediately open and inspect inventory for the affected products. Results of the inspection are to be provided to Medisystems and the product is to be returned to Medisystems. For questions call (978) 332-5973.
Quantity in Commerce 16 cases (15 cs x 250 ea) 4,000 needles
Distribution US Nationwide Distribution in the states of NY, PA and TN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FIE and Original Applicant = MEDISYSTEMS CORP.
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