Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1116-2013 — 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 batte

U.S. FDA — Device Enforcement · United States · 2013-03-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1116-2013
Date of alert: 2013-03-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Hospira Inc.
Product category: device
Product type: Devices

Reported risk: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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