Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Reported: September 18, 2013 Initiated: August 5, 2013 #Z-2166-2013
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.
Details
- Recalling Firm
- B. Braun Medical, Inc.
- Units Affected
- 900
- Distribution
- Distributed in the states of FL, NY, NJ, and TX.
- Location
- Allentown, PA
Frequently Asked Questions
What product was recalled? ▼
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.. Recalled by B. Braun Medical, Inc.. Units affected: 900.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2013. Severity: Moderate. Recall number: Z-2166-2013.
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