Z-0913-03

Custom Kit

Name: Z-0913-03 Custom Kit
Creator: Merit Medical Systems, Inc
Published: 2003-05-16
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2003-05-16 / Terminated

FDA source

Merit Medical Systems, Inc began a recall of Custom Kit on 2003-05-16. The reason FDA records is "Cracks in the syringe barrels could allow for air aspiration into the syringe barrel". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0913-03
Status: Terminated
Initiated: 2003-05-16
Posted: 2003-06-05
Terminated: 2003-07-21
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Kit
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
FDA root cause: Other
Action: On 5/16/2003, all distributors and consignees were notified by letter.
Quantity in commerce: 20 kits
Distribution: Nationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.
Product codes and lots: REF/CAT No.: K09-03442C. Lot No. A259058

Product code DQO

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)