Class 2 Device Recall Horizon Pump Metriset Burette Set

• Date Initiated by Firm: April 18, 2007
• Date Posted: May 31, 2007
• Recall Status: Terminated 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/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Boulevard; Allentown PA 18109-9512
• For Additional Information Contact: Kimberly Paris; 610-266-0500
• Manufacturer Reason for Recall: Secondary infusion backs up into primary container.
• FDA Determined Cause: Other
• 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.