Home / Recalls / Medisystems a NX Stage Company / Z-0714-2013

Z-0714-2013 Class II Terminated

Recalled by Medisystems a NX Stage Company — Lawrence, MA

Recall Details

Product Type: Devices
Report Date: January 30, 2013
Initiation Date: December 20, 2012
Termination Date: October 10, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26 casesx 250 needles (6500needles)

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".

Distribution Pattern

US Nationwide Distribution in the states of NY, PA and TN.

Code Information

Lot: 120719F4