FDA recall Z-0688-2018

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

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.

Distribution

US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain

Key facts

Status

Terminated

Initiation date

2017-12-14

Report date

2018-02-28

Termination date

2020-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0688-2018