Home / Recalls / Nipro Medical Corporation / Z-0599-2016

Z-0599-2016 Class III Terminated

Recalled by Nipro Medical Corporation — Miami, FL

Recall Details

Product Type
Devices
Report Date
January 13, 2016
Initiation Date
April 1, 2014
Termination Date
December 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
160,000 pieces.

Product Description

NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.

Reason for Recall

Device has the potential to have torn wings.

Distribution Pattern

US distribution including TN.

Code Information

Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.

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  • Z-0161-2016 Class II — Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood ac (August 13, 2015)
  • Z-0624-2016 Class II — NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protector (March 30, 2015)
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  • Z-0134-2013 Class II — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hyd (July 27, 2012)
  • Z-0138-2013 Class II — AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hy (July 27, 2012)