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

Recall Z-0069-2013 — Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, ele

U.S. FDA — Device Enforcement · United States · 2012-08-29 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0069-2013
Date of alert: 2012-08-29
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Hospira Inc.
Product category: device
Product type: Devices

Reported risk: The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the 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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