Z-0941-2011

Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South...

Name: Z-0941-2011 Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South...
Creator: Merit Medical Systems, Inc.
Published: 2010-12-17
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-12-17 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. Intended to provide access and facilitate... on 2010-12-17. The reason FDA records is "Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0941-2011
Status: Terminated
Initiated: 2010-12-17
Posted: 2011-01-28
Terminated: 2011-07-11
Recalling firm: Merit Medical Systems, Inc.
Product: Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. Intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. Can also provide access to a native or synthetic graft used for hemodialysis.
Product code: DYB Introducer, Catheter
Reason for recall: Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response.
FDA root cause: Component change control
Action: Merit Medical Systems, Inc., issued an "Urgent Product Recall Notice" dated December 17, 2010, and contacted all customers (sales reps and authorized distributors) via email, phone and/or fax. The notice described the product, problem and action to be taken by the customers (Sales reps/Distributors). The customers were instructed to contact all their customers to identify, quarantine and return all unused inventory and extend the recall to any of their customers who may have received the affected products. The customers were instructed to complete and return the Manufacturer RECALL NOTIFICATION and Product Retrieval Form via fax to 1-801-208-3378 and send original to: the Manager, Customer Service, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, UT 84095-2416. Questions should be directed to the Senior Product Manager at 801-208-4344 or the Manager, Customer Service at 801-208-4365.
Quantity in commerce: 378 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: H179575

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)