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Medisystems a NX Stage Company recalls Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with Mast
Recalled January 30, 2013 · FDA recall Z-0715-2013 · Medisystems a NX Stage
Hazard
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge · FDA Class II
Units
16 cases (15 cs x 250 ea) 4,000 needles
Sold at
US Nationwide Distribution in the states of NY, PA and TN.
Description
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
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
Manufacturer(s)
Medisystems a NX Stage Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →