Reported Jan 30, 2013 · Terminated
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with…
Medisystems a NX Stage Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medisystems a NX Stage Company · 350 Merrimack St · Lawrence, MA · 01843-1748
Is this the product you have?
- Medisystems 17 Gauge x 1"
- inch AV Fistula Needle Product CodeD9-2007MGLB
- Product UsageMedisystems 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
- Lot codes and dates
- LotNumber: 110914F8
- Amount recalled
- 16 cases (15 cs x 250 ea) 4,000 needles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
This product could cause temporary or reversible health problems — stop using it.
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