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Early Alert: Convenience Kit Issue from AVID Medical
The FDA is aware that AVID Medical has issued a letter to affected customers recommending convenience kits affected by the BD ChloraPrep Applicator Recall be removed from where they are used or sold. This recall is due to a fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides.
Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death. If the fungus is introduced into a patient's bloodstream during placement of an intravascular catheter, the catheter would likely need to be removed, requiring an additional procedure. Infection at a surgical site may also necessitate medical and surgical intervention, as well as long term treatment with antifungal medications.
This action applies to products previously identified in an AVID Medical notification sent on July 14. Be advised that the actions required for certain lots in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company) regarding their ChloraPrep applicators. Following the initial notification, BD provided additional information regarding its recall of ChloraPrep Clear 1 mL Single Sterile applicators (BD lot 4032183).
As of August 6, AVID Medical has not reported any serious injuries or deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
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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