Recall Z-0691-2017— B. Braun Medical, Inc.

Name: FDA recall Z-0691-2017
Creator: U.S. Food and Drug Administration
Published: 2016-07-29

Class II · Terminated

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2016-07-29, terminated 2018-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures. Reason: Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot..

Recalling firm: B. Braun Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-29
Terminated: 2018-03-06
Firm location: Allentown, PA, United States

Product description

Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

Reason for recall

Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

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