Medical Device Safety and Recalls: The FDA Recommends Health Care Providers Stop Using Customed, Inc. Surgical Convenience Packs and Trays: FDA Safety Communication

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

Title: Medical Device Safety and Recalls: The FDA Recommends Health Care Providers Stop Using Customed, Inc. Surgical Convenience Packs and Trays: FDA Safety Communication

The FDA has recently posted a safety communication for health care providers and staff working at health care facilities or hospitals in Puerto Rico regarding the use of Customed, Inc. Surgical Convenience Packs and Trays.  The integrity, safety and efficacy of these products cannot be assured because adequate testing has not been completed to assure:

• The sterility of the products,
• That endotoxin and ethylene oxide levels are within safe limits,
• That package integrity can withstand stresses during transport, and
• That the products will be effective up to their expiration dates.

These deficiencies pose a risk of serious adverse health consequences, such as infection and death.  For more information, see the safety communication in English or in Spanish.

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