FDAFDA · Food and drugs·Recall number Z-0714-2013
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.
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
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
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: 120719F4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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