Z-1699-2008

Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan...

Name: Z-1699-2008 Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan...
Creator: Merit Medical Systems, Inc.
Published: 2008-04-15
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-04-15 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095 on 2008-04-15. The reason FDA records is "Convenience kits may be non-sterile due to inadequate package sealing". 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-1699-2008
Status: Terminated
Initiated: 2008-04-15
Posted: 2008-09-04
Terminated: 2008-09-03
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Convenience kits may be non-sterile due to inadequate package sealing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.
Quantity in commerce: 10 kits
Distribution: MO. Foreign distribution to Japan. No military or government distribution.
Product codes and lots: Lot Number F594282

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)