Device recall

Z-2446-2010: Disposable Detachable Monopolar Needle Electrode for electromyograph model…

FDA device recall · Class II · Chalgren Enterprises Inc

Key facts

Recall number (Z-number) Z-2446-2010
Recall event 56183
Product Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
Product code IKT
Recalling firm Chalgren Enterprises Inc
Recall class Class II
Status Terminated
Termination date Mar 24, 2011
510(k) numbers K912283
FEI number 2939713

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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