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

Recall Z-2164-2013 — Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower tha

U.S. FDA — Device Enforcement · United States · 2012-10-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2164-2013
Date of alert: 2012-10-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: B Braun Medical, Inc.
Product category: device
Product type: Devices

Reported risk: This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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