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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-0713-2008
Recall Event ID 45907
Product Classification Suction Irrigation Device for Laparoscopy - Product Code FQH
Product Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy
Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411
Code Information All un-expired lots are being recalled.   ASP 105 ASP 145: Lot Serial # 7030294 ASP14502001 ASP14504101517  ASP14504023142 ASP1455022514 ASP1454110199 ASP14503019 ASP14502001 ASP14503019 ASP14503017 ASP14503019 ASP14503017 ASP14502001 ASP14503017 ASP14502001 ASP14504023142 ASP14504101517 ASP14504023142 ASP14504101517 ASP14504110200 ASP1455022514 ASP1454110199 ASP1455031783 ASP1454110199 ASP1455031783 ASP1455041217 ASP1454110199 ASP1455041217 ASP1455052183 ASP1455041217 ASP1455033506 ASP1455041217 ASP1455052183 ASP1455041217 ASP1454110199 ASP1455041217 ASP1455052183 ASP1454110199 ASP1455052183 ASP 150: Lot serial # ASP15002001 ASP 180: Lot Serial #7044270 7044267 04041932 
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 154
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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