Z-0688-2018Class II

PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007...

Name: Z-0688-2018 PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007...
Creator: Merit Medical Systems, Inc.
Published: 2017-12-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2017-12-14 / Terminated

FDA source

Merit Medical Systems, Inc. began a recall of PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5... on 2017-12-14. FDA classified it as Class II and gives the reason as "Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0688-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-14
Posted: 2018-02-22
Terminated: 2020-07-10
Recalling firm: Merit Medical Systems, Inc.
Product: PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
Product code: DYB Introducer, Catheter
Reason for recall: Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
FDA root cause: Under Investigation by firm
Action: Communication to consignees began on December 14, 2017. Merit requested that consignees stop using the PreludeSNAP devices for human use, discontinue distribution, and return remaining product to Merit Medical.
Quantity in commerce: 60,945 devices
Distribution: US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain
Product codes and lots: Lot Numbers: Q1176348 Q1178762 Q1194660 Q1206565 Q1201803 Q1209475 Q1213042 Q1228339 Q1234189X1 Q1234639 Q1182862 Q1190097 Q1194661 Q1197055 Q1202959 Q1213024 Q1215467 Q1234979 Q1174112 Q1197331 Q1176349 Q1213048 Q1182863 Q1228338 Q1194041 Q1206577 Q1214620 Q1184987 Q1194664 Q1213051 Q1237072 Q1213018 Q1205118 Q1175815 Q1194665 Q1197054 Q1193985 Q1193397 Q1209478 Q1228340 Q1176347 Q1204708 Q1182836 Q1170938 Q1161477 Q1185050 Q1234958 Q1176345 Q1193391 Q1228356 Q1175817 Q1194663 Q1215702 Q1228354 Q1201789

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0688-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0688-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-22

Product code DYB

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)