Class 2 Device Recall

• Date Initiated by Firm: May 25, 2005
• Date Posted: July 16, 2005
• Recall Status: Terminated on December 14, 2006
• Recall Number: Z-0998-05
• Recall Event ID: 32177
• 510(K)Number: K822806 K832287 K841639
• Product Classification: Catheter, Flow Directed - Product Code DYG
• Product: Right Heart Catheter Product Line: Catalog Number 601272------WP1106 Wedge Press Cath.
• Code Information: Catalog Number 601272. Lot Number, Exp. Date: 0060460588, 6/30/05; 0060478671, 6/30/05; 0060499553, 9/30/05; 0060514303, 10/31/05; 0060541506, 12/31/05; 0060558250, 3/31/06; 0060707682, 7/31/06; 0060715898, 8/31/06; 0060721686, 9/30/06; 0060724934, 9/30/06; 0060741461, 12/31/06; 0060746728, 1/31/06.
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Lori Sands; 856-751-2080
• Manufacturer Reason for Recall: Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
• FDA Determined Cause: Other
• Action: The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.
• Quantity in Commerce: 172 units
• Distribution: Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
• 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 = DYG