Z-1804-2008

Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking...

Name: Z-1804-2008 Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking...
Creator: Merit Medical Systems, Inc.
Published: 2008-04-08
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-04-08 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah... on 2008-04-08. The reason FDA records is "Convenience kits may contain non-filtered drip chambers". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1804-2008
Status: Terminated
Initiated: 2008-04-08
Posted: 2008-09-11
Terminated: 2009-04-06
Recalling firm: Merit Medical Systems, Inc.
Product: Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Convenience kits may contain non-filtered drip chambers
FDA root cause: Mixed-up of materials/components
Action: An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter.
Quantity in commerce: 113 kits
Distribution: Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
Product codes and lots: Lot Number F604890

Product code FPA

K915678Class IIMerit Administration SetMerit Medical Systems, Inc. / cleared 1992-07-30

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)