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Recall Observatory FDA recall evidence

Device product

Merit Inflation Syringe Kit. Catalog Number KOS-02857

Z-0002-2017

August 25, 2016

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 75127
Status
Terminated
Classification
Class II
Quantity
1,297 total units
Official record key
device-enforcement:Z-0002-2017

Official wording

Reason: Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

Code information: Lot Numbers: H959038, H970334, H984351.

Distribution pattern: One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.