FDA-Device2013-01-30Class II
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.
Medisystems a NX Stage Company
Hazard
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Sold states
US Nationwide Distribution in the states of NY, PA and TN.
Affected count
26 casesx 250 needles (6500needles)
Manufactured in
350 Merrimack St, N/A, Lawrence, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0714-2013Don't want to check this manually?
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