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

FDA device recall Z-0714-2008 · posted 2008-04-03 · Terminated

Recall details

Recalling firm

Coloplast Corp

Reason for recall

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

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.

Root cause

Process design

Status

Terminated

Product code

FQH

Quantity affected

559

Distribution

Nationwide, including Puerto Rico.

Date initiated

2007-11-12

Date posted

2008-04-03

Date terminated

2008-11-04

Location

Minneapolis, MN