> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Don’t Use Customed Packs, Trays: FDA
- URL: https://www.fdaweb.com/dont-use-customed-packs-trays-fda/
- Published: 2016-01-05T12:00:00.000Z
- Updated: 2026-09-15T02:25:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134338

> FDA has issued a medical device [safety communication](http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm479509.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) urging healthcare providers in Puerto Rico and staff at healthcare facilities or hospitals in Puerto Rico not to use Customed convenience packs and trays for any surgical procedures. The notice says that the integrity, safety and efficacy of the products can’t be assured because adequate testing has not been done to assure product sterility, 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.  
>  
> The notice says that Customed recalled its surgical convenience packs 6/3/14 due to potentially compromised sterility caused by the plastic packaging of one unit sticking to adjacent units during the sterilization process. A 7/14/14 FDA inspection disclosed deficiencies concerning the validation of the sterilization process and packaging design. A 12/9/14 Warning Letter confirmed the deficiencies.  
>  
> FDA says the company initiated a second recall 10/8/14 that expanded the previous recall and added surgical convenience trays. Both recalls were listed by the agency as Class 1.  
>  
> The company stopped distributing products from 10/8/14 to 11/21/14 and then resumed manufacturing without informing FDA, the notice says. FDA also learned that the products were being distributed in Puerto Rico by the Puerto Rico Hospital Supply company. A follow-up inspection was conducted 4/6-4/29/15 at which the agency determined that the corrective actions specific to ethylene oxide sterilization validation and package integrity testing were still inadequate and incomplete.  
>  
> In 7/2015, Customed issued additional recalls for products distributed between 11/21/14 and 6/23/15, due to continued issues with the validation of the sterility and packaging of contents in the convenience packs and trays.  
>  
> “Due to its persistent concerns with products still in distribution, FDA recommends customers not use these products,” the notice concludes.