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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Medical's Custom Procedural Tray

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 Class 2 Recall
Merit Medical's Custom Procedural Tray
see related information
Date Posted January 10, 2013
Recall Status1 Terminated on January 14, 2013
Recall Number Z-0663-2013
Recall Event ID 63231
Premarket Notification
510(K) Number
K090882 
Product Classification Saline, Vascular Access Flush - Product Code NGT
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.
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
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
12701 N Kingston Ave
Chester, Virginia 23836-2700
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Joyce G. Braxton
804-416-1048
Manufacturer 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
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the 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 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.
Quantity in Commerce 422 total kits/trays
Distribution Distributed in Mississippi and New Jersey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NGT and Original Applicant = HOSPIRA, INC.
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