FDAFDA · Food and drugs·Recall number Z-2166-2013
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Published September 18, 2013 · Recall initiated: August 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B. Braun Medical, Inc.
- Distributor
- Distributed in the states of FL, NY, NJ, and TX.
- Lot
- Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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