Z-0621-03

Custom Angiographic Kit

Name: Z-0621-03 Custom Angiographic Kit
Creator: Merit Medical Systems, Inc
Published: 2003-02-13
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2003-02-13 / Terminated / root cause: sterility

FDA source

Merit Medical Systems, Inc began a recall of Custom Angiographic Kit on 2003-02-13. The reason FDA records is "A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0621-03
Status: Terminated
Initiated: 2003-02-13
Posted: 2003-03-06
Terminated: 2003-03-07
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Angiographic Kit
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
Root cause tag: sterility
FDA root cause: Other
Action: Consignees were notified by phone and FAX on 2/12/2003.
Quantity in commerce: 100 kits.
Distribution: FL and Japan.
Product codes and lots: Model Number: K08-MP5130. Lot Numbers: A146066, A188604.

Product code DQO

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)