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U.S. Department of Health and Human Services

Class 2 Device Recall Horizon Pump Metriset Burette Set

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  Class 2 Device Recall Horizon Pump Metriset Burette Set see related information
Date Initiated by Firm April 18, 2007
Date Posted May 31, 2007
Recall Status1 Terminated 3 on April 22, 2008
Recall Number Z-0819-2007
Recall Event ID 37856
510(K)Number K955585  K904518  
Product Classification IV Set - Product Code FPA
Product Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets.
Code Information Lot numbers: 60888186 exp 9/11 and 60869008 exp 6/11
Recalling Firm/
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
Manufacturer Reason
for Recall
Secondary infusion backs up into primary container.
FDA Determined
Cause 2
Action The recalling firm issued Product Removal Notices on 4/20/07 via certified priority mail. The notice informed the customer of the problem and the need to return the product.
Quantity in Commerce 2.5 million for all products
Distribution Nationwide and Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = FPA and Original Applicant = KENDALL MCGAW LABORATORIES, INC.