Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
FDA Recall Z-2166-2013 · Posted 2013-09-06
Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-08-05
Date Terminated2014-09-03
Product Quantity900
Reason for Recall
Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.
Firm Action
On August 4, 2013, a letter was sent to direct accounts asking them to check their inventory for the affected product. These customers were also instructed to notify their customers if the product was further distributed and to return all affected product and/or the product removal acknowledgement form.
Root Cause
Process control
Distribution Pattern
Distributed in the states of FL, NY, NJ, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.