Z-0080-06

Merit Custom Procedure Kit

Name: Z-0080-06 Merit Custom Procedure Kit
Creator: Merit Medical Systems, Inc
Published: 2005-09-02
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2005-09-02 / Terminated

FDA source

Merit Medical Systems, Inc began a recall of Merit Custom Procedure Kit on 2005-09-02. The reason FDA records is "Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0080-06
Status: Terminated
Initiated: 2005-09-02
Posted: 2005-10-21
Terminated: 2005-10-28
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Custom Procedure Kit
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
FDA root cause: Other
Action: Consignees were notified by letter on 9/2/2005.
Quantity in commerce: 372 units
Distribution: DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.
Product codes and lots: Part Number: K09-05248AP. Lot Numbers: A348563, A360799, A365773, A370274, A372525, A377402, A382733, A388638, F392744.

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