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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun Outlook Safety Infusion System Burette Set

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 Class 2 Recall
B. Braun Outlook Safety Infusion System Burette Set
see related information
Date Posted September 06, 2013
Recall Status1 Open
Recall Number Z-2166-2013
Recall Event ID 65993
Premarket Notification
510(K) Numbers
K904518  K921860  K955585 
Product Classification Pump, Infusion - Product Code FRN
Product Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Code Information Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown, Pennsylvania 18109-9512
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact B.Braun Customer Service
610-266-0500
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On August 4, 2013, a letter was sent to direct accounts asking them to check their inventory for the affected product. These customers were also instructed to notify their customers if the product was further distributed and to return all affected product and/or the product removal acknowledgement form.
Quantity in Commerce 900
Distribution Distributed in the states of FL, NY, NJ, and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = FRN and Original Applicant = KENDALL MCGAW LABORATORIES, INC.
510(K)s with Product Code = FRN and Original Applicant = MCGAW, INC.
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