martes, 5 de enero de 2016

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

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