Class 2 Device Recall Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with GBS Coating

• Date Initiated by Firm: November 28, 2005
• Date Posted: March 01, 2006
• Recall Status: Terminated on June 21, 2007
• Recall Number: Z-0575-06
• Recall Event ID: 34220
• 510(K)Number: K040355
• Product Classification: Oxygenator, Cardiopulmonary Bypass - Product Code DTZ
• Product: The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula.
• Code Information: 315402, 307412, 336406, 010506, 067511, 080507, 171510, 220523, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 0535818, 180501, 348420, 053515, 249512, 125515, 157527, 178525, 130500, 241500, 133500, 320408, 234515, 285417, 313418, 334408, 024507, 053510, 117501, 122508, 151509, 210510, 220526, 224519, 328415, 053511, 067515, 157509, 178520, 199510, 266509, 067518, 101520, 220530, 270503, 348400
• Recalling Firm/ Manufacturer: Gish Biomedical Inc; 22942 Arroyo Vis; Rancho Santa Margarita CA 92688-2600
• For Additional Information Contact: Edward F. Waddell; 949-635-6200
• Manufacturer Reason for Recall: The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.
• FDA Determined Cause: Other
• Action: The firm faxed all initial consignees a letter notifying them of the recall and the affected lots involved. The consignee was instructed to immediately inspect their inventory, and if any units of the affected product remain, the consignee is to contact Gish Biomedical Customer Service at 866-221-9911. The consignee is to provide catalogue number, lot number and quantity and state the reason for replacement is the recall letter. Gish Customer Service, in conjunction with the sales representative and customer pack office, will work with the consignee in an effort to resolve inventory and configuration issues.
• Quantity in Commerce: 1, 216
• Distribution: CA, FL, IN, MA, MI, NJ, NY
• 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 = DTZ and Original Applicant = GISH BIOMEDICAL, INC.