Recall Z-0663-2013— Merit Medical Systems, Inc.

Name: FDA recall Z-0663-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-14

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2012-09-14, terminated 2013-01-14. It names one FDA 510(k) clearance: K090882. Product: 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.. 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.

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-14
Terminated: 2013-01-14
Firm location: Chester, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K090882 — FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDEHospira, Inc.·cleared 2010-04-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.