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/ 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 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
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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.
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