FDA-Device2013-01-30Class II
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
Medisystems a NX Stage Company
Hazard
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
Sold states
US Nationwide Distribution in the states of NY, PA and TN.
Affected count
16 cases (15 cs x 250 ea) 4,000 needles
Manufactured in
350 Merrimack St, N/A, Lawrence, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2013Don't want to check this manually?
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