Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: ...
FDA Recall #Z-0714-2013 — Class II — December 20, 2012
Product Description
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.
Reason for Recall
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Recalling Firm
Medisystems a NX Stage Company — Lawrence, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
26 casesx 250 needles (6500needles)
Distribution
US Nationwide Distribution in the states of NY, PA and TN.
Code Information
Lot: 120719F4
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated