—#121164

Product

Outlook Safety Infusion System Burette Set. For intravenous fluid administration.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K904518, K921860, K955585
Affected lot / code info: Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Distributed in the states of FL, NY, NJ, and TX.

Timeline

Recall initiated: 2013-08-05
Posted by FDA: 2013-09-06
Terminated: 2014-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.