Class 2 Device Recall IBC FloProbe

• Date Initiated by Firm: April 22, 2005
• Date Posted: July 12, 2006
• Recall Status: Terminated on July 18, 2006
• Recall Number: Z-1223-06
• Recall Event ID: 35704
• 510(K)Number: K963703
• Product Classification: Probe, Blood-Flow, Extravascular - Product Code DPT
• Product: IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX.
• Code Information: Lot #122004-100217 and #030805-100279.
• Recalling Firm/ Manufacturer: International Biophysics Corp; 2101-2 E Saint Elmo, Ste 275; Austin TX 78744
• Manufacturer Reason for Recall: Complaints received regarding the device's failure to zero out.
• FDA Determined Cause: Other
• Action: Firm notified customers via e-mail and phone calls starting on 04/22/05.
• Quantity in Commerce: 7,502
• Distribution: Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees.
• 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 = DPT