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Terminated

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

FDA Recall Z-0688-2018 · Posted None

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-12-14
Date Terminated2020-07-10
Product Quantity60,945 devices

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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