Customed, Inc. Issues Recall of Sterile Convenience Kits-Trays, Bags, and New Lots Added to the Previous Recall

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Customed, Inc. Issues Recall of Sterile Convenience Kits-Trays, Bags, and New Lots Added to the Previous Recall

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Customed, Inc. Issues Recall of Sterile Convenience Kits-Trays, Bags, and New Lots Added to the Previous Recall

11/25/2014 12:03 PM EST

On October 8th, 2014 Customed, Inc. initiated a recall of sterile convenience surgical kits-trays, bags (known as "Convenience Kits"), and New Lots Added as follow-up to the June 3, 2014 Class I recall of 233 sterile convenience surgical kits. The Convenience kits have a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection.

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