Device recall

Z-2565-2014: Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak…

FDA device recall · Class II · Bio-Detek, Inc.

Key facts

Recall number (Z-number) Z-2565-2014
Recall event 68970
Product Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033
Product code MKJ
Recalling firm Bio-Detek, Inc.
Recall class Class II
Status Terminated
Termination date Jun 17, 2015
510(k) numbers K033771
FEI number 1218058

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

Browse all FDA device recalls (products)