Medical Device Safety and Recalls: Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems

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

Title: Medical Device Safety and Recalls: Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems

A recall has been issued for Customed Inc., Surgical Convenience Packs.  These surgical convenience packs may not be sterile because there were problems with how they were made and stored by the manufacturer before they were sent to customers. The use of the recalled product may cause health consequences for the patient, such as infection and death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm427938.htm

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