Recall Z-2166-2013— B. Braun Medical, Inc.

Name: FDA recall Z-2166-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-05

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2013-08-05, terminated 2014-09-03. It names 3 FDA 510(k) clearances: K955585, K921860, K904518. Product: Outlook Safety Infusion System Burette Set. For intravenous fluid administration.. Reason: 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-05
Terminated: 2014-09-03
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K955585 — V2 INJECTION SITEB.Braun Medical, Inc.·cleared 1996-05-15
K921860 — MODIFICATION TO IV SPIKEMcgaw, Inc.·cleared 1992-07-30
K904518 — VOLUMETRIC INFUSION PUMPKendall Mcgaw Laboratories, Inc.·cleared 1990-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.