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Terminated

Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets

FDA Recall Z-0837-2011 · Posted 2011-01-10

Recalling FirmB Braun Medical, Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-08-24
Date Terminated2014-05-29
Product Quantity2,107 Pumps (582 Pumps to Winchester)

Reason for Recall

Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation.

Firm Action

B. Braun Medical Inc. notified consignee by letter on August 24, 2010.

Root Cause

Component design/selection

Distribution Pattern

Virginia and New York

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011975HORIZON OUTLOOK WITH DOSECOMB.Braun Medical, Inc. · 2001-09-19K994375HORIZON LIGHTB.Braun Medical, Inc. · 2000-03-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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