Class 2 Device Recall Elefant Suction Irrigation Device

• Date Initiated by Firm: November 12, 2007
• Date Posted: April 03, 2008
• Recall Status: Terminated on November 04, 2008
• Recall Number: Z-0715-2008
• Recall Event ID: 45907
• Product Classification: Suction Irrigation Device for Laparoscopy - Product Code FQH
• Product: Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411
• Code Information: All un-expired lots are being recalled. AST 307: Lot Serial# AST30702104
• Recalling Firm/ Manufacturer: Coloplast Corp; 1525 W River Rd; Minneapolis MN 55411-3430
• For Additional Information Contact: 612-287-4178
• Manufacturer Reason for Recall: Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
• FDA Determined Cause: Process design
• Action: Coloplast sent customers an "Urgent: Recall Notification" letter on 11/12/07. The letter described that the sterilization of the products was not performed according to ISO 11135 standard. The notification requested the customers to return the product immediately and to send a fax or contact the company via email in regard to inventory at hand. A phone script for distributors also included an advice to discontinue dispensing the product and to fax or email in regard to inventory at hand.
• Quantity in Commerce: 4
• Distribution: Nationwide, including Puerto Rico.
• 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.