Z-0557-2011

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South...

Name: Z-0557-2011 Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South...
Creator: Merit Medical Systems, Inc.
Published: 2010-10-25
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-10-25 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA on 2010-10-25. The reason FDA records is "Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint". 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-0557-2011
Status: Terminated
Initiated: 2010-10-25
Posted: 2010-12-08
Terminated: 2012-03-23
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.
Quantity in commerce: 1033 units
Distribution: Nationwide Distribution in the states of CA, IL, IN, and UT.
Product codes and lots: Lot No.: H137939, H147372, H151609, H158544

Product code DQO

K913682Class IIMerit Custom KitMerit Medical Systems, Inc. / cleared 1991-11-15

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)