Z-0745-2010

Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095...

Name: Z-0745-2010 Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095...
Creator: Merit Medical Systems, Inc.
Published: 2009-01-29
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2009-01-29 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience when... on 2009-01-29. The reason FDA records is "A manufacturing defect may prevent adequate sterilization of the entire device". 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-0745-2010
Status: Terminated
Initiated: 2009-01-29
Posted: 2010-01-29
Terminated: 2011-06-16
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: A manufacturing defect may prevent adequate sterilization of the entire device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm. For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution -- United States ( PA and TX) and Japan.
Product codes and lots: Lot number: F565427.

Product code OEZ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)