Class 2 Device Recall B. Braun HyperFormer Pump Dispensing Set

• Date Initiated by Firm: April 11, 2007
• Date Posted: May 05, 2007
• Recall Status: Terminated on August 07, 2007
• Recall Number: Z-0783-2007
• Recall Event ID: 37855
• 510(K)Number: K905201
• Product Classification: HyperFormer Pump Dispensing Set, - Product Code LHI
• Product: B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.
• Code Information: Lot number 0060911602
• 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: The integrity of the sterile product barrier may be compromised
• FDA Determined Cause: Other
• Action: An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.
• Quantity in Commerce: 180 units
• Distribution: Nationwide distribution --- including states of GA, MA, OH, and TX
• 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 = LHI