January 5, 2016: FDA Recommends Hospitals Desist Usage of Customed Surgical Packs and Trays

Customed Surgical Packs and Trays

The U.S. Food and Drug Administration (FDA) issued a Safety Communication cautioning hospitals and health care facilities in Puerto Rico to desist using Customed, Inc. Surgical Convenience Packs and Trays. The FDA asks these facilities to avoid these products due to unassured “integrity, safety, and efficacy”. Specifically, the FDA has not been able to test:

    • 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.

Customed Surgical Packs and Trays

The Surgical Convenience Packs and Trays manufactured by Customed, Inc are used during any surgical procedure, and include many surgical tools and assist items. The packs include exam gloves, absorbent towels, suture bags, surgical table covers and drapes. The trays include odium chloride irrigation bottles, catheters, needles and syringes.

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If you are a loved one has been seriously injured by Customed Surgical Packs and Trays or any medical device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form”, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

Customed, Inc

This product had been recalled June 2014, and again in October 2014. In November 2014, however, Customed, Inc resumed manufacturing tray and packs without informing the FDA. When the product was inspected again in April 2015, the product was again found to be inadequate in several safety and efficacy tests. Due to this failure as well as lack of inspection, the FDA highly recommended that health care professionals discontinue use of this product.

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