FDAFDA · Food and drugs·Recall number Z-0715-2013
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
Published January 30, 2013 · Recall initiated: December 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Medisystems a NX Stage Company
- Distributor
- US Nationwide Distribution in the states of NY, PA and TN.
- Lot
- Lot: Number: 110914F8
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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