Z-2166-2013Class II

Outlook Safety Infusion System Burette Set. For intravenous fluid administration

Name: Z-2166-2013 Outlook Safety Infusion System Burette Set. For intravenous fluid administration
Creator: B. Braun Medical, Inc.
Published: 2013-08-05
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2013-08-05 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Outlook Safety Infusion System Burette Set. For intravenous fluid administration on 2013-08-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2166-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-05
Posted: 2013-09-06
Terminated: 2014-09-03
Recalling firm: B Braun Medical Inc
Product: Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 900
Distribution: Distributed in the states of FL, NY, NJ, and TX.
Product codes and lots: Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2166-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2166-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-06

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)