Home / Recalls / Medtronic Advanced Energy, LLC / Z-1134-2017

Z-1134-2017 Class II Terminated

Recalled by Medtronic Advanced Energy, LLC — Portsmouth, NH

Recall Details

Product Type
Devices
Report Date
February 8, 2017
Initiation Date
December 28, 2016
Termination Date
May 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
326 units

Product Description

Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

Reason for Recall

Product sterility compromised due to breach of sterile barrier

Distribution Pattern

Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.

Code Information

All lot codes

Other recalls by Medtronic Advanced Energy, LLC

  • Z-1128-2017 Class II — Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Dispos (December 28, 2016)
  • Z-1132-2017 Class II — Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disp (December 28, 2016)
  • Z-1130-2017 Class II — Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Dispos (December 28, 2016)
  • Z-1133-2017 Class II — Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Dispos (December 28, 2016)
  • Z-1126-2017 Class II — Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Dispos (December 28, 2016)
  • Z-1136-2017 Class II — Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Dispos (December 28, 2016)
  • Z-1131-2017 Class II — Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Dispos (December 28, 2016)
  • Z-1129-2017 Class II — Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disp (December 28, 2016)
  • Z-1127-2017 Class II — Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Dispos (December 28, 2016)
  • Z-1135-2017 Class II — Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disp (December 28, 2016)