FDA-Device2013-01-16Class II
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.
Merit Medical Systems, Inc.
Hazard
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
Sold states
Distributed in Mississippi and New Jersey.
Affected count
422 total kits/trays
Manufactured in
12701 N Kingston Ave, Chester, VA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0663-2013Don't want to check this manually?
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