Coloplast Corp Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411
Brand
Coloplast Corp
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Coloplast Corp is recalling Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145 due to Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026