Z-0847-2007

Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah

Name: Z-0847-2007 Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah
Creator: Merit Medical Systems, Inc.
Published: 2007-04-17
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2007-04-17 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah on 2007-04-17. The reason FDA records is "Male luer in fluid administration sets may crack due to inadequate molding process". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0847-2007
Status: Terminated
Initiated: 2007-04-17
Posted: 2007-05-31
Terminated: 2008-05-05
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.
Product code: FMG Stopcock, I.V. Set
Reason for recall: Male luer in fluid administration sets may crack due to inadequate molding process
FDA root cause: Other
Action: Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.
Quantity in commerce: 17 units
Distribution: CA, IL, NJ, NY. No military, government or foreign distribution.
Product codes and lots: Lot number V536479.

Product code FMG

K915678Class IIMerit Administration SetMerit Medical Systems, Inc. / cleared 1992-07-30

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)