Home / Recalls / Medical Devices
Medisystems a NX Stage Company recalls Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole
Recalled January 30, 2013 · FDA recall Z-0714-2013 · Medisystems a NX Stage
Hazard
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". · FDA Class II
Units
26 casesx 250 needles (6500needles)
Sold at
US Nationwide Distribution in the states of NY, PA and TN.
Description
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
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.
Manufacturer(s)
Medisystems a NX Stage Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →