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Terminated

Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411

FDA Recall Z-0715-2008 · Posted 2008-04-03

Recalling FirmColoplast Corp
Recall StatusTerminated
Product CodeFQH
Date Initiated2007-11-12
Date Terminated2008-11-04
Product Quantity4

Reason for Recall

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

Firm 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.

Root Cause

Process design

Distribution Pattern

Nationwide, including Puerto Rico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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