Z-0578-2009

Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095

Name: Z-0578-2009 Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095
Creator: Merit Medical Systems, Inc.
Published: 2008-09-12
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-09-12 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 on 2008-09-12. The reason FDA records is "Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748". 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-0578-2009
Status: Terminated
Initiated: 2008-09-12
Posted: 2009-01-13
Terminated: 2009-01-13
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All consignees were notified by sales reps via phone, fax or visit between 09/15/2008 and 10/09/2008. Sales reps were to instruct them to immediately discontinue use and quarantine all affected products. A Product Retrieval Form was to be completed and signed by the customer's site representative. More information available at 801-316-4998.
Quantity in commerce: 399 kits
Distribution: United States including the states of AR, AZ, CA, CO, FL, KY, IL, IN, MA, MI, MN, MO, NJ, NY, PA, SC, TX, UT, VA, WI, and WV. No military or foreign distribution. VA facilities in CA and FL.
Product codes and lots: Lot number F622787

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)