—#95391

Product

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K011975, K994375
Affected lot / code info: Model No. 621-400ES. Premarket Notifications K011975 and K994375. Device Listings D051037 and D051592.

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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

Recalling firm

Firm: B Braun Medical, Inc
Address: 1601 Wallace Dr, Ste 150, Carrollton, Texas 75006-6690

Distribution

Distribution pattern: Virginia and New York

Timeline

Recall initiated: 2010-08-24
Posted by FDA: 2011-01-10
Terminated: 2014-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95391. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.