Merit Medical's Custom Procedural Tray 의 리콜

Recall

63231

Class 2

Z-0663-2013

2012-09-14

2013-01-10

Terminated

United States

2013-01-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113073

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.

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.