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The FDA is aware that AVID Medical has issued a letter to affected customers recommending certain convenience kit be corrected prior to continued use by removing components affected by the Huons Co., Ltd. recall.
AVID Medical stated that epidural kits may contain sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices, LLC, due to concerns of product quality and sterility assurance in the Sodium Chloride Injection 0.9%, USP 10ml. The use of sodium chloride ampules may expose patients to viable microorganisms, endotoxins, and foreign matter that may trigger inflammatory responses and infections. This consideration is of particular importance in critically ill patients and when treatment is administered in close proximity to organs highly susceptible to injury — such as the spinal cord — where it may predispose to abscess formation and subsequent paralysis.
As of August 10, AVID Medical has reported no serious injuries and no deaths associated with this issue.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact AVID Medical at complaints@owens-minor.com.
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