Merit Medical Systems, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0663-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Merit Medical's Custom Procedural Tray or Kits K12T-03162B &amp; 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.

Product Classification:

Class II

Date Initiated: September 14, 2012

Date Posted: January 16, 2013

Recall Number: Z-0663-2013

Event ID: 63231

Reason for Recall:

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

Status: Terminated

Product Quantity: 422 total kits/trays

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.

Voluntary or Mandated:

Voluntary: Firm initiated