Z-0518-2010

Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH...

Name: Z-0518-2010 Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH...
Creator: Merit Medical Systems, Inc.
Published: 2009-09-29
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2009-09-29 / Terminated / root cause: sterility

FDA source

Merit Medical Systems, Inc. began a recall of Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and... on 2009-09-29. The reason FDA records is "Potential sterility breach caused by excessive shipment damage". 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-0518-2010
Status: Terminated
Initiated: 2009-09-29
Posted: 2009-12-14
Terminated: 2009-12-15
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.
Product code: DYB Introducer, Catheter
Reason for recall: Potential sterility breach caused by excessive shipment damage.
Root cause tag: sterility
FDA root cause: Other
Action: Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
Quantity in commerce: 1 Short Sheath
Distribution: US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
Product codes and lots: Lot #: F732268S1

Product code DYB

K082063Class IIPrelude Short Sheath IntroducerMerit Medical Systems, Inc. / cleared 2008-10-15

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)