Class 2 Device Recall IBC Suction Wand

• Date Initiated by Firm: August 16, 2005
• Date Posted: July 12, 2006
• Recall Status: Terminated on July 17, 2006
• Recall Number: Z-1222-06
• Recall Event ID: 35703
• 510(K)Number: K841959
• Product Classification: Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
• Product: IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.
• Code Information: Lot #042805-100335.
• FEI Number: 1000117854
• Recalling Firm/ Manufacturer: International Biophysics Corp; 2101-2 E Saint Elmo, Ste 275; Austin TX 78744
• Manufacturer Reason for Recall: Tyvek pouches containing device labeled as sterile have defective seals.
• FDA Determined Cause: Other
• Action: Firm notified customer via telephone on 08/16/05.
• Quantity in Commerce: 179 units.
• Distribution: Product distributed to one hospital located in FL.
• 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 = DWE