Device recall

Z-1170-2013: The GemStar Pump is a small and lightweight, single channel infusion device…

FDA device recall · Class I · Hospira Inc.

Key facts

Recall number (Z-number) Z-1170-2013
Recall event 64837
Product The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline…
Product code FRN
Recalling firm Hospira Inc.
Recall class Class I
Status Terminated
Termination date Mar 10, 2017
510(k) numbers K083019
FEI number 3013319212

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

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