Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Me...
FDA Recall #Z-0715-2013 — Class II — December 20, 2012
Product Description
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
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
Recalling Firm
Medisystems a NX Stage Company — Lawrence, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
16 cases (15 cs x 250 ea) 4,000 needles
Distribution
US Nationwide Distribution in the states of NY, PA and TN.
Code Information
Lot: Number: 110914F8
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated