CharterMedical.com creates custom engineered solutions for the medical industry
Title
Charter Medical, Ltd. A Lydall Company
Description
As you are aware, Charter Medical initiated a recall in January 2005 of ethylene oxide (EtO) sterilized products. We have completed the notification process and now need to address the disposition of returned and quarantined products.
Charter Medical has presented a disposition proposal to FDA’s Atlanta District which includes repackaging and resterilization of both products that were returned due to recall or quarantined at Charter Medical prior to distribution. Charter Medical has completed validation of a new EtO sterilization cycle. All reworked devices will be repackaged and sterilized through the new cycle.
In order to avoid confusion in the field, Charter Medical is making every effort to ensure that these lots are easily distinguishable from other Charter Medical products while still maintaining full traceability. All returned recall products subjected to resterilization will be identified with a –S directly following the lot number. All Charter Medical quarantined product subjected to resterilization will be identified with a –C directly following the lot number. The lot number and manufacture date remained the same on the product label in order to fulfill all traceability requirements.
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- Alexa: CharterMedical.com
