—#113073

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.

FDA product code: NGT — Saline, Vascular Access Flush
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090882
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 and immediately fax a copy of the completed Customer Response Form to: 1-804-416-1031 and mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Consignees were given product return instructions.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 12701 N Kingston Ave, Chester, Virginia 23836-2700

Distribution

Distribution pattern: Distributed in Mississippi and New Jersey.

Timeline

Recall initiated: 2012-09-14
Posted by FDA: 2013-01-10
Terminated: 2013-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.