Recall Z-0714-2008

Coloplast Corp · initiated November 12, 2007

Terminated

Product

Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411

Codes / lots: 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

Reason for recall

Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.

FDA-determined cause: Process design

Action taken

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.

Details

Recall number
Z-0714-2008
Initiated
November 12, 2007
Posted by FDA
April 3, 2008
Terminated
November 4, 2008
Product code
FQH – Lavage, Jet
Quantity
559
Distribution
Nationwide, including Puerto Rico.
Recalling firm
Coloplast Corp, Minneapolis, MN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0713-2008 Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… 11/12/2007Terminated
Z-0715-2008 Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp.…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… 11/12/2007Terminated