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Terminated

Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

FDA Recall Z-0667-2008 · Posted 2008-01-19

Recalling FirmFertility Technology Resources, Inc.
Recall StatusTerminated
Product CodeMQF
Date Initiated2007-09-13
Date Terminated2008-02-06
Product Quantitynot reported

Reason for Recall

Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.

Firm Action

All customers were contacted by telephone starting 9/13/2007. They were asked to return all Tucker family of catheters and all Morton IUI catheters that are on the shelves. A UPS call tag was sent to each customer to facilitate the return of the products. A follow up Urgent Device Recall letter was sent to all customers on 10/9/2007 reminding them to return all outstanding inventory when the UPS call tag arrives.

Root Cause

Process design

Distribution Pattern

Worldwide: USA including states of CA, CO, FL, GA, LA, MD, ME, MI, MS, NC, NH, NJ, NY, OH, TN, and WA and The Netherlands.

Official Source

View FDA Recall →

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

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