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U.S. Department of Health and Human Services

Class 2 Device Recall Elefant Suction Irrigation Device

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  Class 2 Device Recall Elefant Suction Irrigation Device see related information
Date Initiated by Firm November 12, 2007
Date Posted April 03, 2008
Recall Status1 Terminated 3 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/
Coloplast Corp
1525 W River Rd
Minneapolis MN 55411-3430
For Additional Information Contact
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 2
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.