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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-0714-2008
Recall Event ID 45907
Product Classification Suction Irrigation Device for Laparoscopy - Product Code FQH
Product Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers:
ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411
Code Information All un-expired lots are being recalled.   ASP 165: Lot Serial# 04023897 6120192 7021217 7053185 7062896 7062897 7062903 7070016 ASP16502002 ASP16502005 ASP16503040 ASP16503043 ASP16503101459 ASP16503110460 ASP16504023143 ASP16504023897 ASP16504033803 ASP16504061589 ASP16504064478 ASP16504070805 ASP16504074192 ASP1655021255 ASP1655030739 ASP1655031634 ASP1655042461 ASP1655051481 ASP1655052172 ASP1655052174 ASP1655052175 ASP1655052651 ASP1655053628 ASP1655060297 ASP1655060299 ASP1655062276 ASP1655062277 ASP1655070732 ASP1656100365 ASP1656100366 ASP1656120191 ASP1657010843 ASP1657021217 ASP 170: Lot Serial # ASP1701000  
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 559
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.
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