Class 2 Device Recall Adult Metriset w/Cassette

• Date Initiated by Firm: June 30, 2008
• Date Posted: September 23, 2008
• Recall Status: Terminated on May 05, 2009
• Recall Number: Z-2408-2008
• Recall Event ID: 49078
• 510(K)Number: K904518 K921860 K942988
• Product Classification: Intravascular Administration set - Product Code FRN
• Product: Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
• Code Information: Lot number 60998897 exp 3/31/2013
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Boulevard; Allentown PA 18109-9512
• For Additional Information Contact: Customer Support Department; 800-227-2862
• Manufacturer Reason for Recall: incorrect burette was packaged with the product
• FDA Determined Cause: Mixed-up of materials/components
• Action: The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
• Quantity in Commerce: 280 units
• Distribution: Nationwide.
• 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 = FRN; 510(K)s with Product Code = FRN; 510(K)s with Product Code = FRN