Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combina

FDA device recall Z-0663-2013 · posted 2013-01-10 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

NGT

Quantity affected

422 total kits/trays

Distribution

Distributed in Mississippi and New Jersey.

Date initiated

2012-09-14

Date posted

2013-01-10

Date terminated

2013-01-14

Location

Chester, VA

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