Z-0667-2008

Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology...

Name: Z-0667-2008 Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology...
Creator: Fertility Technology Resources, Inc.
Published: 2007-09-13
License: https://open.fda.gov/license/

Fertility Technology Resources, Inc. / initiated 2007-09-13 / Terminated / root cause: manufacturing process

FDA source

Fertility Technology Resources, Inc. began a recall of Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062 on 2007-09-13. The reason FDA records is "Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0667-2008
Status: Terminated
Initiated: 2007-09-13
Posted: 2008-01-19
Terminated: 2008-02-06
Recalling firm: Fertility Technology Resources, Inc.
Product: Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062
Product code: MQF Catheter, Assisted Reproduction
Reason for recall: Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: not reported
Distribution: 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.
Product codes and lots: All units shipped before August 17, 2007

Product code MQF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)