Important Safety Alerts

Important Safety Alerts

Field Safety Notice: B. Braun Infusomat Space Pump - US Version Infusion pump

09 Mar 2012

The Food and Drug Administration (FDA), United States, has issued a Class I recall on B. Braun Infusomat Space Pump - US Version Infusion pump, Model # 8713050U.

FDA reported that the affected device has a potential for breakage of anti free flow clip catch when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced to be closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of the IV set roller clamp, the anti free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow. When the pump and IV set are operated in accordance with the Instructions for Use, the potential for free flow is fully mitigated.

According to the local supplier, the affected device is not distributed in Hong Kong.
For details, please refer to FDA website
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm292057.htm

If you are in possession of the product, please contact your supplier for necessary actions.

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