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Recall Observatory FDA recall evidence

Device product

Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.

Z-0663-2013

September 14, 2012

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 63231
Status
Terminated
Classification
Class II
Quantity
422 total kits/trays
Official record key
device-enforcement:Z-0663-2013

Official wording

Reason: Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the

Code information: Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT

Distribution pattern: Distributed in Mississippi and New Jersey.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate