The Recall Desk

FDA (Devices) recall action 63959

Medisystems a NX Stage Company recalled 2 products on 2013-01-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-01-30
Critical
0
Units
—

Why these products were recalled

Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge

A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2013-01-30

    Medisystems 17 Gauge AV Fistula Needles Recalled for Mislabeling

    Medisystems is recalling 17 Gauge AV Fistula Needles because single needle packs are mislabeled as 15 Gauge. The recall covers 4,000 needles distributed in New York, Pennsylvania, and Tennessee.

    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
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2013-01-30

    Medisystems Buttonhole Needle Set Recalled for Mislabeled Length

    Medisystems is recalling 5 mislabeled buttonhole needle pouches that were labeled as 15 Ga x 1 inch instead of 15 Ga x 3/5 inch.

    Product
    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
    Category
    Distribution
    3 states