Recall Z-0663-2013 ยท NGT Saline, Vascular Access Flush
Merit Medical Systems, Inc.
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.
| Date | Jan 10, 2013 (initiated Sep 14, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Merit Medical sent an "URGENT PRODUCT RECALL NOTICE" dated September 14, 2012 to all affected customers. The letter identified the affected product, description of problem and recommended user actions to be taken. Consignees were requested to ensure that all appropriate personnel are notified of the affected Merit trays so that they can take immediate action. They were instructed to quarantine all affected kits, remove the bag of 0.9% Sodium Chloride and return the affected product to Merit for credit or replacement. Consignees were requested to complete and sign the Customer Response Form |
| Quantity | 422 total kits/trays |
| Distribution | Distributed in Mississippi and New Jersey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090882 | FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE Hospira, Inc., Apr 23, 2010 |